Clinical Trial Podcast | Conversations with Clinical Research Experts (Kunal Sampat | Educator)

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO).

Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations. 

Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate.

In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional.

You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a “Lessons Learned” document and much more. We wrap up on a very topic of growth versus fixed mindset. 

My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable).

Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum.

Show Notes:

Antoinette (Torres) Frankum on LinkedIn

• Project Manager versus Program Manager: what is the difference? 
• Technical skill sets needed to become an effective clinical project management professional
• Creating and managing study timelines including tools such as Microsoft Gantt
• Understanding your stakeholders in clinical research
  • Investigators
  • Patients
  • Regulatory authority
• Understanding your stakeholders in clinical research
• Managing patient expectations
• Managing resources and budget
• How to assess clinical trial risks as a CRO?
  • Feasibility 
  • Identify what is going to impact timeline, budget, resources
  • Quality issues
• The right way to conduct a brainstorming session with your team
• Why you should conduct lessons learned during the close-out phase?
• Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset)
• Helping your executive team by problem-solving
• Effective communication strategies with senior leadership
• Sites and CROs are on the same team
• It is okay to make mistakes
• Communication and people skills will help you grow faster
• Asking for feedback and ways to improve as a clinical research professional

Books Mentioned:

Mindset: The New Psychology of Success by Carol S. Dweck

The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are by Brené Brown

Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead by Brené Brown

Clinical trials are conducted in compliance with regulations. 

Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices.

As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework.

To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show.

In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States.

She does a great job of tailoring our conversation to make it applicable for clinical trial professionals.

We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more.

The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic.

Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast.

Podcast Sponsor: This episode is brought to you by Florence Healthcare. To learn more, visit florencehc.com

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

• Connect with James

LinkedIn

• Medicare
• International Society for Pharmacoeconomics and Outcomes Research (IPSOR)
• BIO conference
• Stanford Biodesign Program
• Centre for Health Economics at University of York
• The National Institute for Health and Care Excellence (NICE)
• What is a MAC?
• Hospital Readmissions Reduction Program

Books Mentioned:

• Leading at Mach 2 by Steve Sullivan
• Good to Great by Jim Collins
• The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell
• Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios
• Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance

Show Notes:

• What is Health Economics [01:52]
• James’s personal story: career path to HEOR [06:09]
• Daily routine of HEOR professionals [13:26]
• NICE and other HTA [14:30]
• HTA in the United States [15:15]
• HTA vs. MAC [16:30]
• The future of HEOR [18:59]
• Hospital Readmissions Reduction Program (HRRP) [19:58]
• Economic value and what should a medical product start-up do? [24:17]
• How to find HEOR consultants [25:00]
• Qualities of HEOR people [28:06]
• Health economic model: how to make one? [28:57]
• Working with Medicare Administrative Contractor (MAC) [31:38]
• The future of HEOR (continued) [33:20]
• On Big Data [34:57]
• Leveraging HEOR data in countries such as US and Japan [36:52]
• How does HTA function in the US [38:26]
• Resources and guidance documents on HTAs [40:23]
• HTA review process in Japan [43:30]
• Trick to learning other therapeutic areas [47:55]

What was most useful for you in this episode? Leave me a comment below and thanks for listening.

Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem

The traditional model involves sponsors and CROs contracting with trial sites and hoping the sites will find and enroll eligible patients. 

Through her work at monARC Bio, Komathi Stem is flipping the traditional model upside down. 

In this interview, Komathi shares how patients can now share medical records for clinical research purposes. 

Pharmaceutical and medical device companies can then leverage this data to easily identify potential clinical research patients.

With the rapid growth of software technology and high pressure to keep medical costs down, there is a growing need and application of real-world data in clinical research. 

For this reason, we are likely to see a rapid use of technology and the use of real-world data in clinical research and trial management. 

In this interview, we’ll cover the following topics:

• Why does monARC exists and what it does? 
• Data generated through routine clinical care and how to aggregate it
• Patient powered registries 
• Role of support groups, social media, clinician, and advocacy groups
• Mobile application to collect data between the clinical
• Understanding patient journey
• Geotargeting patients using Facebook
• Traditional versus “real-world” clinical trial
• Looking at the natural progression of the disease via a natural history study
• • getting data on patients with no intervention
• Measuring treatment impact with a digital endpoint
• Impact of the intervention of Quality of Life (QoL)
• Challenges with real-world data 
• • Access to the data
  • Different formats and need for standardization
• Speed of decision making in big pharma
• Creating a sense of urgency using storytelling
• Importance of developing trusted relationships
• Future of electronic data capture (EDC) with the rise of real-world projects
• The current state of EDC and EHR integration
• Accelerating Research through Collaboration

To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast. 

SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and facilitate the process by reducing barriers for sites and participants.

Prior to the launch of SiteBridge, Chris has held various leadership roles at PPD, GlaxoSmithKline, Accenture and ZS Associates.

Chris holds a B.S. in Systems Engineering from the University of Virginia and an MBA from Duke University and resides with his wife and three children in Chapel Hill, NC.

Please join me in welcoming Chris on the Clinical Trial Podcast.

Sponsors:

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. 

In other words, the success rate was 21%.

And the total funding amount was $8,827,444,624.

The question I had was, “What does it take to get grant approval and launch an NIH funded research project?”

To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children’s Hospital Emergency Center in Houston. 

Dr. Shah has served on several national committees to advocate for improvements in pediatric and prehospital emergency care. 

His research has focused on developing, implementing, and studying outcomes related to evidence-based protocols for various clinical conditions, including seizures. 

Dr. Shah is currently the Principal Investigator for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study, which has been funded by the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted in the Pediatric Emergency Care Applied Research Network (PECARN).

Please join me in welcoming Dr. Shah on the Clinical Trial Podcast. 

This episode is brought you by Florence Healthcare. To learn more, please visit https://florencehc.com/

Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients.

Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges.

To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network.

Dr. Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world.

In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology.

After finishing his PhD in Neurology and Neurosurgery, Graham worked at MDS Pharma Services, Cetero Research, Manna Research and Altasciences as well as spending two years working at biotechnology companies.

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This podcast is brought to you by Slope.

Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. 

To learn more, visit slope.io and ask to speak with a solutions coordinator today. 

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This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective.

 

The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment. 

 

The goal is to bring more awareness on how to prevent patient recruitment failure and complete enrollment as planned.

 

1. Initial funding insufficient to reimburse recruiting staff/sites
2. Context-specific logistic obstacles (e.g., urgent transfers from intensive care, different treatment availabilities at different centers or on weekends)
3. Lack of methodological/logistical support (e.g., from contract research organization or clinical trial unit)
4. Prejudice against effectiveness of trial interventions 
5. New evidence from other study about effectiveness of trial interventions
6. Administrative burden/time constraints 
7. Lack of eligible participants - Overestimated prevalence (mostly reported as overly narrow eligibility criteria)
8. Concurrent competing trials
9. High burden (e.g., many visits, invasive procedure, questionnaires, costs) 

To learn more and get detailed show notes, visit clinicaltrialpodcast.com

Podcast Sponsor: This episode is brought to you by Florence Healthcare. 

Clinical trial finance is a key area of clinical trials and clinical research. 

Human beings are innately not good with numbers and clinical trial finance is no exception. 

Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional. 

This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances. 

In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances.  

Blake is currently an Associate Director, Clinical Research at Abbot Labs.  

I’m excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets. 

We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more. 

I hope you enjoy this interview with Blake. 

Blake Peters on LinkedIn.

• How does one make a transition into clinical research?
• Core skills
• • Bringing value to your team
  • Helping clinical project managers forecast and estimate clinical trial costs
  • Excel skills
  • Data analytics
  • Financial mindset
  • Continued curiosity to learn and grow
• Transitioning from finance to clinical research 
• • Learning about the conduct of clinical trials
  • Therapeutic knowledge
  • On the job training
  • A clinical research training conference
• Working with clinical project manager on finances 
• • Challenging clinical trial assumptions to optimize financing
  • Historic data on benchmarking
• Hospitals are required to publish procedure costs
• Collaboration with finance on clinical trials and research
• • Alignment on vocabulary, a common understanding of what each if try to talk about
• Maslow’s Law of Hierarchy for Clinical Trial Costs 
• • Cost of the clinical trial - a list of expense type
  • Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses
  • Timing of these expenses 
  • Factors that change the cost
  • Total trial cost 
• Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource
• • Review project management fees
  • Review monitoring costs
  • Categorize costs into buckets or functional costs (safety, data management, operations, etc.)
• Becoming proficient in Microsoft Excel 
• • What do you find yourself doing manually and/or repeatedly?
  • Be resourceful
  • Spending 5-10 minutes can save you tens or hundreds of hours
  • Research solutions (Youtube, Google) and implement
• Powerpoint skills in clinical research 
• • Understanding the message
  • Meeting with the stakeholders
  • Think about table vs. graphs vs. graphics
  • Don’t overdo animations
  • First, get the content on the slide and then focus on the aesthetics of your slides
  • Iterate, hit save and look at it again the next morning
• Types of PowerPoint slides
• • Speak for itself with clean design
  • Reference manual 
  • Different audience/ use cases
• Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you
• Valuable skills for clinical research professionals
• • Listening
  • Public speaking/ storytelling
• Passion and inspiration
• Managing stress with diet, meditation, drinking a lot of water 

Resources mentioned:

• Abbott

What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

One of the biggest challenges in clinical study start-up and conduct is “training.”

A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more. 

With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary.

In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx.

Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training.

We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more.

I hope you enjoy my conversation with Joel Selzer on Clinical Trial Readiness. 

 

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.

Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.

At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle.

Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more.

In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more.

Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman. 

Sponsors:

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

In this interview, I had the opportunity to speak with Ahmed Hamouda. 

Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field.

I’ve been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region. 

If you’ve been site and country selection meetings trying to determine whether you want to conduct trials in Egypt but have more questions than answers, this interview is for you. 

You’ll hear Ahmed breakdown the exact clinical trial conduct process in Egypt step-by-step.

Ahmed has worked in a wide variety of professional capacities over different regions and markets in the Middle East, Gulf, Europe, and Asia.

He is a pharmacist by education and received his MBA in 2013. Aside from being a clinical research professional, Ahmed likes to dive and explore new cultures.

Show Notes:

Ahmed Hamouda on LinkedIn

• Ahmed’s background and experience working in the Middle East 
• Value of conducting trials in the Middle East
• • A large population of over 300 million people
  • 21 countries in the region
  • Prevalence of diseases such as cardiovascular and hypertension
• Reasons why some Sponsors and CROs are not doing research in Egypt
• • Lack of awareness of Egypt’s capabilities 
  • Long approval times for exporting blood samples 
• Importation process for medical products in Egypt
• • Certificate of Analysis and quality documents
• Site Start-up Process
• • Select sites
  • Secure IRB approval (~1 month)
  • Ministry of Health Approval i.e. MoH (~2 months)
  • • Observational trials can start right away
    • Interventional trials require additional review (see below)
  • Interventional trials (~2 months)
  • • Biological are submitted to The National Organization for Research and Control of Biologicals (NORCB)
    • Non-biological are submitted to The National Organization for Drug Control and Research (NODCAR)
  • Importing investigational medical product (IMP)
  • Central Administration of Pharmaceutical Affairs (CAPA)
• Role of MoH vs. NORCB/ NORDCAR
• • MoH will review study-specific documents such as protocol, eCRFs, CVS, patient-facing materials, insurance, patient diaries, signed contracts, etc.
  • NORCD/ NODCAR will review information specific to the investigational product
• Process for adding more sites midway through the study
• Trial classification in Egypt - Phase I, II, III
• IRB rejections (decline) and how they are managed
• Product approval and commercialization 
• • The concept around open-box vs. close box
  • Pricing file is the limiting factor
  • Naming list
  • Pharmacovigilance (PV) files
• Contracts and Budgets
• • Required at the time of IRB and/or MoH submission 
  • Exceptions are handled via Sponsor/ CRO generated commitment letters
• Clinical Trial Research Units in Egypt 
• Allocation of budget and distribution between the site and the investigator
• Use of clinical trial contract templates 
• Contracts are in English and Arabic
• High-quality translations are achieved with the help of medically trained and certified translation company
• Site selection process 
• Lack of computerized system at the site can cause issues
• Career advancement for clinical research professionals in Egypt
• Social responsibility on part of CRO

Other Resources:

• RAY CRO
• Pharma Med, a medical translation company
• ICH GCP Guidelines

My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation.

In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to treat patients with post traumatic stress disorder (PTSD).

PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds. 

As you’ll hear from Rebecca shortly, the clinical data from the recent clinical trial looks extremely promising. 

This interview will leave you with excellent insights on differences and challenges of conducting research with psychedelic drugs including site selection, patient recruitment, clinical trial design considerations and more. 

I am beyond excited to discuss this important topic of psychedelic research on the podcast. 

Please join me in welcoming Rebecca Matthews on the Clinical Trial Podcast. Enjoy!

Podcast Sponsor

This interview you brought you Florence Healthcare.

Transform your Clinical Trials with the #1 Platform for Electronic Document Workflows and Remote Site Access.

Learn how Florence Healthcare helps over 7,200 research sites, sponsors, and CROs across 27 countries take their day back from paper.

In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs). 

These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient enrollment initiatives, publication plan, and more.

Although it entirely possible to conduct these meetings virtually (and sometimes you’re better off conducting them virtually), the focus of this episode is on in-person meetings. But most meetings tend to poorly organized with lack of purpose and defined objectives i.e. what is it that you hope to achieve by conducting this meeting. If you’re directly or in-directly involved in organizing a meeting with KOLs, this episode will serve you well.

This episode is brought to you by Calyx. To learn more on how Calyx can help you with your medical imaging needs, please visit calyx.ai

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. 

Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. 

Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning.

JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy’s Diversity, Equity, Inclusion and Belonging Advisory Board.

JoAnne received her undergraduate, law and master of business administration degrees — all with honors — from Washington University in St. Louis. 

Please join me in welcoming JoAnne on the Clinical Trial Podcast. 

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

 

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training.

Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan.

Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs).

In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more.

Please join me in welcome Jessie to the Clinical Trial Podcast.

Show Notes:

• Getting into clinical research via technical roles such as data management and biometrics
• What makes a great statistician?
• Experience gained working for a big and small company
• Writing a statistical analysis plan
• Making CRO-Sponsor relationship work and how to succeed with outsourcing
• Getting unstuck - understanding how CROs and sponsors work
• Identifying clinical safety gaps and plugging in a CRO
• Protecting yourself as a sponsor when you outsource safety
• Working with CRO through iterations and why RACI may not work for you
• Outsourcing clinical events committee (CEC) and data safety committee (DMC)
• MEDRA coding: how it works, automation, generic versus specific coding
• Reducing CRO/ outsourcing budget and how to do it?
• Evolution of CRA role - drafting a protocol to writing reports
• Key Performance Indicators (KPIs) for a clinical research organization
• Turnover at a CRO and why it matters
• Financial KPI - money spent relative to the actions that were supposed to happen with that money
• Developing a process mindset - 5 major things that need to happen from beginning to end
• Evaluating employee performance relative to others
• Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results  
• Volunteer yourself to get involved
• Moving beyond conference calls and emails - pick up the phone and talk to someone
• Clinical research is about working in a field where your work really matters

 

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe?

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials.

To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show.

Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. 

I hope you enjoy this conversation with Dr. Oren Cohen.

Podcast Sponsor:

This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit calyx.ai 

 

To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast. 

Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs)

Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics.

Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin. 

She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore. 

Sponsor(s):

This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​.

In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more.

Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and

Enjoy!

Sponsor(s):

This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​

 

In this episode, we’re going to talk about Postmarket Surveillance Studies. 

In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. 

The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device. 

To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast.

David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations. 

David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs. 

David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant. 

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This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com 

This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

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This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager. At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements. Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources. Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I’ll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role. Thanks to my blog reader Christopher B. for recommending this topic. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below.

About This Podcast Episode:

Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

• Connect with me (Kunal)

LinkedIn | Twitter

• The Ultimate Guide to Clinical Trial Costs
• FDA Good Clinical Practice Guidance
• Learn Microsoft Excel and other Microsoft Office Tools
  • SkillShare
  • Udemy
  • YouTube
• Microsoft Office Products
  • Microsoft Project to create timelines
  • Microsoft Excel to create and manage study budgets and timelines
  • Office Timeline, a Microsoft Powerpoint plugin that helps you create beautiful clinical trial timelines
• Create graphics and slides using Canva

Books Mentioned:

• Sapiens: A Brief History of Humankind by Yuval Noah Harari
• The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future by Kevin Kelly

Show Notes:

• Protocol, follow-up requirements and adverse event reporting [01:26]
• Understanding the clinical procedure [4:42]
• Good Clinical Practice [6:02]
• Managing a clinical study budget [7:20]
• Proficiency with Microsoft Excel [8:22]
• Developing and executing on study timelines [14:41]
• Managing study resources [22:05]
• Paying attention to compliance [24:02]
• Being self-aware [28:13]
• Being objective in your decision-making process [29:40]
• Being proactive and results driven [31:04]
• Ask questions and be curious [32:58]
• Explain your thought process [36:40]
• How to communicate effectively [38:05]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast.

Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. 

He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device approval or indications in the US), has authored more than 3000 manuscripts and abstracts published in the peer-reviewed literature, and has delivered thousands of invited lectures around the world. 

With an H-index of 202, Dr. Stone has been recognized in Nature Medicine as one of the most prolific authors in science, and by the Web of Science as among the top 0.01% of cited researchers in science. 

Dr. Stone completed medical school at Johns Hopkins University Medical Center, in Baltimore, MD, and his internship and residency at the New York Hospital-Cornell Medical Center in New York City. 

He completed his general cardiology fellowship at Cedars-Sinai Medical Center in Los Angeles, CA and subsequently a dedicated fellowship in advanced coronary angioplasty in Kansas City, MO. 

Please join me in welcoming Dr. Gregg Stone on the Clinical Trial Podcast.

Sponsor(s):

This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

Many people tout about technical skills in clinical research.

You need to know Microsoft Excel.

You need to understand Good Clinical Practice.

You need to memorize the FDA guidance documents.

Have you ever heard someone talk about soft skills in clinical research?

I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager.

When you work with a diverse team, you must master soft skills.

Soft skills, also known as “real skills”, help you learn, adapt and grow. 

In this interview, I invited Ed Hogan, Executive Vice President (EVP) at Invicro, to talk about soft skills in clinical research.

Ed and I first met in 2005. He was the Director for Medical Imaging at PAREXEL/ Perceptive Informatics, my first job out of college.

Ed is now responsible for overseeing the clinical services team which includes project management, imaging services, data management and reader management for early and late phase clinical trials.

Ed has close to three decades of experience in clinical research, managing, and executing Phase I through Phase IV imaging trials in both the Pharmaceutical and CRO space. 

He is THE expert when it comes to medical imaging operations.

Ed has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements.

For these reasons, I invited Ed to talk to us about soft skills including negotiating contracts, how to develop a successful manager-employee relationship, what Ed looks for when he is wanting to promote someone on his team, leading effective meetings and much more. 

I hope you enjoy my conversation with Ed to the Clinical Trial Podcast

[3:50] Soft skills and project management

[4:54] Negotiating contracts with Sponsor including cost, study design, and operations

[7:25] Offer Sponsors what they need and not nice-to-have elements 

[8:24] Clinical project managers are involved in finances  

[10:22] Ideally Sponsor should ideally have a direct communication with imaging CRO

[11:59] Example of risk mitigation in clinical trials 

[13:39] Developing soft skills through PMP certification and courses and on the job training

[14:45] Managing and working with project team members

[17:21] Developing a strong team with diverse and complementary skills

[19:01] Putting in time and practice to develop your skills

[21:01] Soft skills are not easy to do

[22:28] Key ingredients that make a successful manager-employee relationship

[23:52] Giving direct and timely feedback 

[25:37] Feedback “sandwich”

[26:32]  Managers can plan and prepare before giving feedback. (a) State the outcome, (b) state the issue, (c) listen, (d) reinforce your intent to help, (e) repeat the end goal and expected outcome, (f) followup with an email

[28:51] Practical advice on managing up

[31:54] Giving and getting feedback from your colleagues 

[34:06] Developing writing skills

[36:01] Understand pain points to create winning proposals

[37:23] Finance skills such as dealing with budgets, ability to write and communicate effectively, multitasking, time management, learning styles are some of the skills Ed focuses on when  promoting or hiring someone new

[40:41] Getting your foot in the door with entry level clinical research roles 

[45:54] Dealing with emotional employees when giving feedback 

 

Resources Mentioned:

Never Split the Difference with Chris Voss

Project Management Professional (PMP) curriculum

Radical Candor by Kim Scott

StrengthsFinder 2.0 by Gallup (Author)

The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni

Myers Briggs Personality Test

Official Microsoft Excel Video Training

The 7 Habits of Highly Effective People by Stephen R. Covey

Harvard Business Review for managers

Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones by James Clear

James Clear’s newsletter

“You have to forgive yourself and not expect perfection” - Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space. If you’re a gal (or a guy) wanting to transition into clinical research or change roles at your current company, Robin will inspire you with her personal story. We wrap up our discussion with top-notch resources in the interventional cardiology space. I hope you enjoy this interview with Robin as much as I did. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

• Connect with Robin

LinkedIn

• TVT Conference
• TCT MD
• FDA Resources
  • Drugs
  • Medical Devices
  • Biologics
• Gray Sheet
• Cardiac Interventions Today
• Graphics Design: 99Designs

Show Notes:

• Transitioning from R&D engineering to clinical research [02:39]
• Leading clinical safety and working independently [10:50]
• What it takes to switch roles [13:41]
• Finding mentors within clinical organization [16:08]
• Creativity in clinical research [19:01]
• Importance of marketing and messaging in clinical research [23:19]
• Tips and insights for CROs responsible for creating newsletters [29:18]
• How to get credibility among your peers, industry, understanding why something is important in the grand scheme of things [35:25]
• Attending conferences [37:27]

QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

“Life is an adventure” - Gary Thompson

In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson. Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on career choices, his #1 advice for all managers, and the relationship between money and happiness. In his free time, Gary loves to sail and is a proud owner of two sailboats. We discuss how sailing and clinical research are related in more ways than you can imagine. Enjoy my interview with Gary!

Selected Links from the Episode

• Dr. Melvin P. Judkins
• Japan Ministry of Health
• Hobart “Hobie” Alter

Show Notes:

• Advice on how to get into clinical research [1:20]
• Working in Japan [7:33]
• In-direct career paths [11:10]
• How to decide when considering a new clinical role [13:12]
• What it takes to work in a new geography [19:22]
• Most valuable lesson for all managers [23:26]
• Succeeding in the absence of a typical American childhood [25:56]
• Importance of work life balance [28:38]
• On sailing and how it applies to clinical research [32:46]
• Why you should take time off [41:44]
• Being present and meditation [43:30]
• Calling friends and family during the daily commute [47:20]
• Taking advantage of the right opportunities [57:30]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region).

Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials and PSPs in the MENA region and much more.

This interview was recorded shortly after the explosion in Beirut in August 2020. I’d like to thank Maha for taking the time to chat even though her city was experiencing such pain.

Maha has a bachelor’s degree from the Arab University of Beirut. She has worked as Clinical Research Coordinator, Clinical Research Associate, Regulatory Affairs Manager, Clinical Project Manager and is currently the Clinical Operations Manager at Phoenix Clinical Research .

Please join me in welcoming Maha on the Clinical Trial Podcast. Maha Dakhloul on LinkedIn

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees.

In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human research protection, ethical trial design, protocol development, development of ethical clinical research policy and practices and much more.

Dr. McNair has more than 15 years of experience in clinical research and drug development strategy. She has designed and provided medical monitoring for Phase 1-4 clinical studies in a variety of therapeutic areas, including multiple oncology indications, hepatitis C, multiple inflammation indications (psoriasis, multiple sclerosis) and other areas.

Dr. McNair is also an adjunct Assistant Professor at Boston University and teaches in the School of Public Health and in the Master’s of Clinical Investigation graduate programs, on the design and conduct of clinical research studies.

She speaks frequently on the ethical conduct of clinical research studies as part of pharmaceutical drug development and improving interactions between ethics committees/ research review boards and the pharmaceutical industry.

Dr. McNair graduated from the University Of Connecticut School Of Medicine and trained in general surgery at Boston University Medical Center. She has a Master’s in Public Health (Biostatistics/Epidemiology and Health Policy), and a Master’s of Science in Bioethics (research ethics).

Please join me in welcoming Dr. Lindsay McNaire on the Clinical Trial Podcast.

This episode is brought to you by CBI Events.

The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics.

Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you.

Some benefits from your participation in this event include:

• Learning strategies on how to ensure data integrity
• Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions
• Finding out about payer approval requirements and uncovering changing business models
• Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic
• And much, much, more.

If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018.

As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive.

So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount.

Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.

 

 

 

Conversation with Clinical Development Veteran Marshall Cool “There are a lot of things we can do, but we want to make sure we’re doing what we want to do” - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

• Connect with Marshall Cool

LinkedIn

• CSU Annual Biotechnology Symposium
• Bristol-Myers Squibb
• Abbott
• Seth Godin Blog
• Center for Disease Control
• National Institute of Health
• Office of Inspector General
• Medical Affairs Strategic Summit (West)
• Medical Affairs Strategic Summit (East)
• ACRP Investigator Initiated and Sponsored Research Interest Group

Books Mentioned:

• The Road to Character by David Brooks
• Chronicles of Narnia by C.S. Lewis and Pauline Baynes
• Linchpin: Are You Indispensable by Seth Godin
• The Checklist Manifesto: How to Get Things Right by Atul Gawande

Show Notes:

• Description of what a clinical researcher does [02:10]
• Early days in clinical research [04:23]
• Roles and responsibilities of a clinical research associate (CRA) [08:55]
• You don’t need an M.D. or Ph.D. to be in clinical research [10:55]
• Relocating for jobs [13:20]
• Transition from pharma to medical device clinical trials [15:55]
• What to do when you lose your job [19:46]
• Getting into the habit of reading and how it can help your clinical research job [26:31]
• Getting to First Patient In (FPI) for a post-approval medical device study [31:50]
• Onboarding a clinical research organization (CRO) [39:15]
• Investigator sponsored studies (non-company sponsored research) [41:30]
• Starting your career in Phase I-III research [45:45]
• Marshall’s #1 advice to listeners [56:30]
• My motivations for starting the Clinical Trial Podcast [1:01:33]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.  

“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich. In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials. Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations.   I hope you enjoy this interview with Dr. Manfred Stapff. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

• Connect with Manfred

LinkedIn

• Lancet
• Drug Information Association (DIA)
• Association of Clinical Research Professionals (ACRP)
• Food and Drug Administration (FDA)
• Journal of Clinical Hypertension
• American Heart Association (AHA)
• New England Journal of Medicine (NJEM)
• TriNetX
• Merck
• Good Clinical Practice
• ICH

Show Notes:

• About TriNetX [02:15]
• The changing landscape in protocol design [04:16]
• How TriNetX is helping scientist and health care organizations [06:57]
• What types of people are companies like TriNetX hiring [10:54]
• Transitioning from general physician for pilots to Merck [13:32]
• Advice for medical school students and graduates interested in clinical research [18:12]
• Working at CROs - what to expect [23:27]
• Why patient enrollment is challenging [25:29]
• Why should sites consider being part of networks such as TriNetX [28:11]
• How clinical (medical) and industry can be advantageous to you [31:08]
• Importance of doing the “dirty work” in clinical research [32:46]
• Importance of doing the “dirty work” in clinical research [32:46]
• Being open to other people’s opinions [36:30]
• Dealing with tension between science and clinical operations [28:43]
• Keeping yourself informed about new clinical treatments and scientific findings [46:41]

QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

Download Episode

“It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” - David Rutledge “Don’t let the place you begin dictate the place you end up” - David Rutledge My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular. David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide. In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience. David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents. Enjoy my interview with David!

Selected Links from the Episode:

• Connect with David Rutledge

LinkedIn

• Six Sigma
• CFDA demonstrates the wisdom of Confucius. He said, “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest.”
• Food and Drug Administration
• Harvard Business Review

Books Mentioned:

• Simple: Conquering the Crisis of Complexity by Alan Siegel and Irene Etzkorn
• Steve Jobs by Walter Isaacson
• Chess Not Checkers: Elevate Your Leadership Game by Mark Miller
• The Art of Asking: How I Learned to Stop Worrying and Let People Help by Amanda Palmer
• Kiss, Bow, Or Shake Hands: The Bestselling Guide to Doing Business in More Than 60 Countries by Terri Morrison and Wayne A. Conaway

Show Notes:

• How to pierce through clinical study reports and making insightful comments [09:45]
• About Six Sigma certification [17:05]
• Three basic skills that will make you a better CRO or medical writer [21:59]
• Developing competency in quality systems [31:05]
• Paying for certifications and training [34:40]
• Guidance for productive one-on-one meetings with managers [37:00]
• Learning from the mistakes of others [40:18]
• Keeping current with latest developments in clinical research industry [42:41]
• Working in China and the CFDA [52:20]
• Taking ownership of your career [1:02:45]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

Ravi Shankar is the founder of FCE Source, a boutique CRO that serves as a strategic partner to medical device companies looking for field clinical engineering support.

FCE, which stands for Field Clinical Engineer, is a specialized role that specifically serves medical device trials. 

FCE is a medical device expert who knows exactly how the medical product needs to be used in the medical setting. In many ways, an FCE is a right hand to the physician. 

In this interview, Ravi does a fantastic job of sharing with us the roles and responsibilities of the FCE, what to expect from an FCE, how to get hired as an FCE and the skills needed to become a great FCE, common mistakes and challenges faced by FCEs, and much more.

Please join me in welcoming Ravi to the Clinical Trial Podcast.

Show Notes:

• FCE provides in-person product expertise in a medical device trial setting (medical device boots on the ground for a clinical trial)
• Difference between Field Clinical Engineer (FCE) and Clinical Research Associate (CRA)
• Can/ should sales representatives serve as FCE on a clinical study?
• History of FCE role and how it all got started in Cardiac Rythm Management (CRM) and pacemaker space 
• Education qualifications such as biomedical engineering needed to become an FCE
• FCE training involves observing in the operating room. You may react a certain way when watching a surgical procedure
• You need to work and learn independently as an FCE
• Studies are not designed keeping in mind the execution. You need to incorporate scientific, marketing, statistical and research coordinator perspective when designing trials
• FCE should not sell. They need to focus on research.
• Visual tools in the operating room (OR), study guide summarizing the protocol, and inclusion/ exclusion cards are helpful 
• How do you find out about job opening for FCE role
• Sponsors need to think of any additional ask as a trade-off with enrollment. Qualify your asks as minor, moderate, or significant
• FCE training would include observing cases, speaking up during cases, developing soft skills, experience with active implantable devices, direct patient interaction, and working in an operating room environment
• Not all FCEs are engineers
• FCE is not practicing medicine. FCE is a coach to physicians and other medical professionals
• FCE needs to be balance action versus learning 
• Salary for FCE is similar to entry-level engineering roles  

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials?

What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients?

Should a Sponsor get access to patient data collected outside a clinical trial setting?

To answer these questions and more, I invited Darshan Kulkarni to the show.

Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker.

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice.

He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.

He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry. 

Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise.

Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry.

This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com

 

Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. 

To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison​ ​Bateman​-​House​, ​PhD​, ​MPH, MA​, ​an​ ​Assistant​ ​Professor​ ​in​ ​the​ ​Division​ ​of​ ​Medical Ethics​ ​at​ ​NYU​ ​Grossman​ ​School​ ​of​ ​Medicine​. 

Dr. ​Bateman​-​House​ ​is​ ​co​-​chair ​of​ ​the​ ​Working​ ​Group​ ​on Compassionate​ ​Use​ ​and​ ​Preapproval​ ​Access​ (​CUPA​), ​an​ ​academic group​ ​that​ ​studies​ ​ethical issues concerning access​ ​to​ ​investigational​ ​medical products​ ​and which consists of patient advocates, clinicians, members of industry, current and former FDA staffers, lawyers, and academics, among others. 

She advises biopharmaceutical companies, patient advocacy organizations, governmental, and non-governmental entities about clinical trial design and non-trial access programs, and she serves as ethicist for numerous data safety monitoring boards overseeing clinical trials. 

She has published and spoken extensively on non-trial access to investigational medical products, ​​equity in clinical​ ​trials​​, individualized therapeutics, ​the​ ​history​ ​and ethics​ ​of​ ​using​ ​humans​ ​as​ ​research​ ​subjects​, and public health ethics. 

Sponsor(s):

This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com 

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/

“Technology makes our lives easier, but it doesn’t replace people” - Melissa “Liss” Easy The dynamic, engaging Melissa “Liss” Easy is the Founder of clinical operations technology provider DrugDev, which is now part of IQVIA. Early in her career Liss was consulting to a Contract Research Organization and became frustrated by inefficiencies in matching investigators to pharma protocols. She started DrugDev to bring sponsors and investigators together by focusing on the needs of the doctors, giving them better technologies and service and more open communication.The DrugDev network Liss began now hosts over 85,000 active investigators in 120 countries in addition to profile and experience information for 450,000+ investigators from 85 pharma and biotech companies. And, DrugDev has expanded to offer a suite of clinical operations solutions used on nearly 2,000 clinical trials.Liss’s honors include being named one of the PharmaVOICE 100 most influential people in life sciences; winning the Partnerships in Clinical Trials Woman of the Year award; and, being named to the a Philadelphia Business Journal Healthcare Innovator.Liss is an extraordinary example of how radical change is creating a new phase in clinical research. I hope you’ll enjoy hearing this extraordinary woman's perspective on how technology can fundamentally change clinical trials and global healthcare for the better.About This Podcast EpisodeListen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” This episode is brought to you by CBI Events CBI has put together an Global Risk Based Monitoring event for clinical research professionals such as yourself. CBIs Global Risk-Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year’s event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM. Register today and get your $500 off your registration using the promo code CTP500. This is an exclusive offer is only available to the Clinical Trial Podcast listeners. Selected Links from the EpisodeDrugDev Society of Clinical Research Sites Why Isn't Your CRO Using E-Consent? Exl Events Investigator Database Bank connecting investigators with sponsors and CROs LastPass, an amazing password management tool SCRS Summit Books Lean In: Women, Work, and the Will to Lead by Sheryl Sandberg Show Notes: Making new pharmaceutical products available to patients who need them sooner [02:20] Making the leap from advertising and marketing  [03:38] Disney to Drugs [05:10] Working on large deals at a CRO and pulling people together from different departments [06:23] Creating like a LinkedIn for investigators and sponsor companies  [07:24] Moving away from contacting physicians via faxes to contacting them via email [08:26] Is there legal or regulatory reason as to why you can't do this in clinical research? [08:50] Reaching out to people your network, asking people what they want and questioning assumptions  [10:19] Electronic patient consent [11:02] Fostering site and industry collaborations via the Investigator Database Bank [13:52] How to make sites lives easier? [15:09] Process for developing strategic partnerships with other organizations [16:22] Everyone wants experienced investigators, but if no one gives them that first chance [18:09] Advice for start-up founders [20:28] Choosing and attending conference [21:47] What are we doing in the 21st century that we must stop doing right now and get ready to change? [22:52] User experience, doing everything just once, and batching tasks [29:42] Once the site is activated, don’t expect them to magically come up with patients [30:34] Ensuring you have a steady study pipeline as a clinical trial site [32:10] Is joining a site network worth it? [35:48] Getting started with new software technologies and importance of staff training [40:04] If you hire someone to do some work, you have to trust them [42:20] Hiring people [43:57] People underestimate how hard it is to manage people remotely [46:17] Building relationships, genuine relationships and being interested in people [47:43] You should listen to people, whether they be more senior or junior than you [49:46] Being a female, there are some additional challenges that you can have in the workplace [54:00] Subscribing to newsletters and attending conferences [55:22] Advice to her younger self [57:55] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

“Just create output. You don't start riding a bike until you take both feet off the ground and push off” - Ryan Jones, CEO, Florence Healthcare Technology is disrupting the clinical research industry. Globally sites, sponsors and CROs are adopting technology to manage risks, to stay competitive, to build a culture that embraces change, to fail fast and to move forward with speed.   In this interview with Ryan Jones, the CEO and Co-founder of Florence Healthcare, we discuss a wide range of topics including how technology is solving some of the biggest problems in clinical trial management, cold calling potential employers, and what it takes to build a healthcare startup. Ryan and his team at Florence have created a beautiful and practical e-source and e-regulatory product that eliminates inefficient clinical workflows. If you’re a clinical trial site, you should definitely check out Florence Healthcare technology solutions for clinical research. Ryan started his career at BCG Global Management Consulting and then became Product Manager for Microsoft Sharepoint. Before founding Florence, Ryan was President of Pubget, which had 600 medical centers and 6 of the 10 largest pharmas as customers. Ryan is a graduate from University of California-Berkeley and Dartmouth College. I hope you enjoy this fun and value-packed conversation with the all-amazing Ryan Jones.About This Podcast EpisodeListen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”This episode is brought to you by CBI Events CBI has put together an Global Risk Based Monitoring event for clinical research professionals such as yourself. CBIs Global Risk Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year’s event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM.Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners. Selected Links from the Episode Connect with Ryan on LinkedIn Ryan’s company Florence Healthcare Emory Healthcare National Cancer Institute Dana Farber Winship ACRPs’ Fundamentals of Clinical Research course Books Zero to One by Peter Thiel Joy, Inc.: How We Built a Workplace People Love by Richard Sheridan Show Notes Building something from nothing when you start a technology company [04:42] Left Microsoft after meeting a physician who was at Harvard [05:17] Hanging around Emory, met a physician who had a problem with task management and workflows and document management [07:32] What is e-regulatory? [08:04] Majority of that software investment is being made by pharma, CRO and device manufacturers for the people that work within their four walls [08:29] Research is done with spreadsheets and three-ring binders today [09:05] Write down the data once and have that data flow efficiently to the Sponsor and FDA [11:28] Two schools of thought in the world of technology for clinical trials [12:11] The history of clinical research since the 1970’s and evolution of change - FDA regulations, Institutional Review Boards (IRB), CRO (Clinical Research Organization), EDC (Electronic Data Capture), and now e-source and e-regulatory [14:52] Five territories - risk management, competition, culture, speed and scale  [18:12] Does the cost of technology offset any savings? [21:33] Best practices for evaluating and adopting new technology in clinical research (a) good checklist (b) internal champion (c) hypothesis of a better world after implementing the technology (d) tiger team to evaluate the software (e) return on investment [23:48] Protocols are getting more complex, work load has doubled, sites are consolidating and sponsors are getting sophisticated with digital tools [26:38] Paying for clinical technology and what’s in for the sponsor or CRO [29:35] Dream team [35:26] You can get a job in clinical research If you don't have the clinical research DNA, but have building DNA or doing DNA [41:26] Cold calling [43:09] Spending time with customers [50:29] Discovering clinical jobs in technology sector [53:12]QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

In this episode, we explore the role of design in clinical trials.

Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials.

One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements. 

To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast.  Ben is the Chief Design Officer and Co-founder at uMotif. Bruce is the Chief Patient Officer & Co-Founder at uMotif.

Please join me in welcoming Bruce and Ben on the Clinical Trial Podcast.

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This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com 

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In this interview with Dr. Jeffrey Kingsley, we talk about what it takes to start and manage a clinical trial site, the world of site networks, how an investigator can decide whether or not a clinical study is worth their time, volunteering for Association of Clinical Research Professionals (ACRP), Food and Drug Administration (FDA) audits, books and a lot more. Dr. Kingsley is the President and CEO; Institute for the Advancement of Clinical Trials DBA IACT Health and an owner of 11 clinical trial sites. He is a Fellow at Association of Clinical Research Professionals. Dr. Kingsley graduated with a master's in business administration from Emory University, a doctorate in osteopathic medicine from Philadelphia College of Osteopathic Medicine, a master's in science, biochemistry and a bachelor's of science, biology, chemistry, history, cultural anthropology from the University of Scranton. Please join me in this value-packed interview with Dr. Jeffrey Kingsley.

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research. 

Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand. 

Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region.

We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management.

I hope you enjoy this energetic interview with Richard Stubbs. 

[Show Notes]

• A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization
• New Zealand has the first world health system
• Investigator and industry-sponsored research in New Zealand 
• Ethics committee approval process 
• Organization’s mission is the education of clinical research site personnel (research coordinators, nurses, administrators)
• Conference every other year and then more frequent regional meetings
• Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template
• Schedule 6 in the contract allows sponsors to add additional verbiage in the contract
• Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019)
• Provisional approved and what it means
• Medical device approval in New Zealand and how it’s different from drug approval
• Regulations in New Zealand for Clinical Research
• Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies 
• • Intellectual property protection
  • No IND needed
  • Fair budget
  • Quick data
  • Quality data
  • Other regulatory bodies trust the data
• New Zealand is part of the Asia Pacific and Japan (APJ) region
• Site Selection in New Zealand 
• • How to find sites
  • What to consider
• Regulatory approval and site start-up processes in New Zealand
• • Site start-up (gathering essential documents as governed by GCP)
  • A centralized and electronic ethics approval process 
  • Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND) 
• Role of the ethics committee in participant reimbursement 
• • Payment to patients generally diminishes with the increase in the phase of the study
• Importance of embedding clinical research in clinical care
• Overhead costs at public and private hospitals in New Zealand
• Only make surplus money out of clinical research is the volume
• Thinking of clinical research in terms of value to patients and their staff
• Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses.
• Value systems in New Zeland such as men and women equality 

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical. 

Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.  She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication. 

Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites.

It goes without saying you need a laptop and stable internet connection to do business in this day and age.

But what else do you need to keep yourself organized as a clinical research site? 

How can a clinical trial site bring most value to their research participants, run a profitable research operation, and not overwork employees with administrative tasks?

To answer these questions and more, I invited Ryan Jones to join me on the show. If this is your first time listening to Ryan, I also invite you to check out my earlier interview with Ryan, Solving Clinical Research Problems Using Technology, episode #12, of the show.

Aside from the technology discussion, I’m a huge fan of the company culture that Ryan and his leadership team at Florence Healthcare have created for their employees. We wrap up the episode with a couple of great book recommendations that you might be interested in reading.

I hope you enjoy my conversation with Ryan Jones.

Ryan Jones on LinkedIn and Twitter 

Florence Healthcare on LinkedIn and Twitter

Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services.

In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials.

Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor’s in Microbiology from University of Illinois

Prior to joining Informed DNA, Karmen was a genetic counselor and research assistant at Oregon Health & Sciences University.

She has been a board member at the Hear See Hope Foundation and Usher Syndrome Coalition. Karmen is also a member of the National Society of Genetic Counselors, member and author of "NSGC Telegenetics Practice Guidelines" Working Group, member of the Association for Research in Vision and Ophthalmology, member and author of American Academy of Ophthalmology Clinical Working group to develop "Recommendations for the Clinical Assessment of Patients with Inherited Retinal Diseases"

Her work has been published in GeneReviews; Current Opinion in Ophthalmology; Investigative Ophthalmology and Visual Science; Ophthalmic Genetics; Archives of Ophthalmology; and Ophthalmology Clinics of North America.

Please join me in welcoming Karmen on the Clinical Trial Podcast.

Topics discussed with Karmen:

• Evolution of genetic testing from one gene at a time to multiple genes at the same time
• Genetic testing in rare diseases such as inherited retinol diseases
• Cost of genetic testing
• Panel testing where multiple genes are tested at the same time
• How genetic tests are regulated
• Clinical trials in genetic testing and the benefits of genetic testing
• Role of a genetic counselor and how they work with patients, sponsors, patient foundations, and medical providers
• Recruitment challenges for sponsors for finding patients with rare diseases
• Use of telemedicine to expand access for patients
• Difference between genome and exome (whole) sequencing
• When is whole genome/ whole exome sequencing clinically relevant/necessary
• Our biggest challenge is trying to manage the volume of data
• Benign versus pathogenic variation in our genes
• What is Variant Interpretation crisis and Variant of uncertain significance (VUS)?
• Why insurance companies are willing to pay for genetic testing to determine the cause of the disease?
• Test the function of a particular genetic variance to:
• • Identify patients
  • Understand which patients qualify for gene therapy
• Very few drugs are approved for gene therapy for genetic diseases
• Antisense Oligonucleotide (ASO) Therapy
• How gene therapy is augmenting abnormal misfolded version of an amyloid
• RNA interference Therapy
• Precision medicine
• Difference between gene editing and gene therapy
• How does one become a genetic counselor?
• Why did we decide to start with gene therapy for retinal disease?
• Challenges with gene therapy
• Informed DNA team consist of genetic counselors primarily responsible for clinical, policy and consulting work
• Standards for panel testing

Starting a career in clinical research with little or no experience can be difficult.

Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization.

In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research. 

We talked about the future of the CRA role and what skills are needed to succeed in today’s marketplace.  

Chris has over 20 years’ experience leading teams and managing clinical trials in the medical device, biotech, and pharma industry.  

At IntersectENT, he serves as Vice President, Clinical and is responsible for developing and managing clinical programs.  

Chris graduated from the University of Louisiana, where he received his Bachelor's degree in Biology and an M.S. degree from George Washington University.

During his spare time, Chris enjoys vacationing in our national parks with his family, trail running, camping, and pretty much every other outdoor activity under the sun.

Please join me in welcoming Chris Lewis on the Clinical Trial Podcast. 

Chris Lewis on LinkedIn

Trainual software for onboarding and SOP training

How to Win Friends and Influence People by Dale Carnegie

Good to Great: Why Some Companies Make the Leap and Others Don't by Jim Collins

Show notes:

• 1:52 Chris unconventional path to clinical research career 
• 2:38 Journey from research coordinator to vice president 
• 3:18 Impact of rise in technology, remote monitoring and risk based monitoring on the CRA’s role
• 5:49 Who is responsible for proctoring clinical trial cases? CRA or Field Clinical Engineer (FCE)
• 6:49 Importance of relationship management, technical expertise, problem solving skills and staying calm in the operating room  
• 8:05 Building interpersonal skills through partnership and collaboration
• 9:34 Consolidation of electronic systems and access to sites 
• 12:25 Process of hiring, interviewing and finding right talent
• 14:31 Leveraging social media (LinkedIn) and internal human resources systems for hiring
• 16:12 Getting to know someone through their hobbies, mannerisms, eager to learn, work hard, and ability to getting along with the rest of the team
• 18:03 The importance and process for having difficult conversations  
• 22:53 Getting the new job posted 
• • Creating clear job description
  • Making a request for requisition
  • Getting it approved through HR and executive
• 23:29 Making an offer
• • Confirm with HR is the requisition is still valid 
  • Obtain executive approval stage
  • Clean communication between the candidate and hiring manager throughout the process 
• 25:58 Onboarding new employees needs to be planned 
• • Create an onboarding plan
  • Clearly articulate and set expectations
  • Training Plan
  • Assign a mentor/ buddy (not their manager)
  • Weekly meetings 
  • Access to systems
• 28:34 Providing ongoing leadership and management 
• 32:33 Core skills i.e. soft skills needed for a  clinical research professionals
• • How to get along with people and see their viewpoints 
  • How to manage a challenging situation
• 36:30 You don’t need two years of experience to get a job in clinical research 
• 38:03 Getting into clinical research career with no experience
• • Getting a masters degree in clinical research 
  • Making contacts and exploring LinkedIn
• 39:19 How does living on the farm impact Chris’s life at work ?
• 41:00 Take control of your career, have patience, get your manager to understand your career aspirations

Resources Mentioned

• Abbott
• Trianual - software solution for onboarding and SOPs
• [Book] The 7 Habits of Highly Effective People by Stephen Covey
• [Book] Good to Great by Jim Collins
• The Clinical Research Administration Program at George Washington University

 

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB. 

Previously she served as senior vice president, research, at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity. 

She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH.

In addition to her academic responsibilities, she currently serves on the Board of Directors of Vivli, Inc., a non-profit organization founded by the MRCT Center dedicated to global clinical trial sharing; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research. 

Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), on the Board of Public Responsibility in Medicine and Research (PRIM&R), and as chair of the Secretary’s Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 240 publications and has served on the editorial boards of a number of journals including Current Protocols of Immunology, Blood, Therapeutic Innovation and Regulatory Science, Ethics and Human Research.

Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.

Please join me in welcoming Dr. Barbara Bierer on the Clinical Trial Podcast. 

This episode is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose.

You’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice.

You’ll also understand key terminology around risks, how to define risk, what's special about clinical studies with respect to risk management, and much more.

Our guest today is Bijan Elahi.

Bijan has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a technical fellow and Medtronic corporate advisor on safety risk management of. medical devices. 

In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. 

Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia.

Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. 

Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing.

Enjoy!

Sponsor:

This podcast is brought to you by Slope.

Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. 

To learn more, visit slope.io and ask to speak with a solutions coordinator today.

In this episode, I share with you strategies and tactical advice on patient recruitment.

Patient recruitment is the foundation of any clinical study.

If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness.

More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and profits for the sponsor but more importantly, the patients that need your therapy won’t get it.

In this podcast, I’m going to share with you 4 amazing strategies that will help you with patient recruitment.

If you’re directly involved in a clinical study as a sponsor, CRO or even a site, this episode is a must-listen. If you’re creating a product or service for clinical research professionals, you need to ensure your work ultimately supports patient recruitment.

Hope you enjoy listening to this solo episode by yours truly.

This episode is brought to you by CBI Events.

The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics.

Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you.

Some benefits from your participation in this event include:

• Learning strategies on how to ensure data integrity
• Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions
• Finding out about payer approval requirements and uncovering changing business models
• Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic
• And much, much, more.

If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018.

As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive.

So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount.

Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.

Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world. 

In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials. 

Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision. 

Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA. 

He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco.

I hope you enjoy my conversation with Mike.

• What is a decentralized or virtual clinical trial? 
• Benefits of a virtual clinical trial in patient recruitment
• The current model of clinical trials where recruitment is done through the doctor
• What does it mean to conduct a decentralized or virtual clinical trial?
• Case Study - CNS trials and how they can benefit from going virtual
  • A limited number of patients (smaller patient pool) 
  • Use of social media to find eligible patients
  • The patient does not need to travel to the doctor’s office, the caregiver goes to the patients home
• Medrio as a technology provider for virtual studies 
  • eConsent
  • Electronic data capture (EDC)
  • Direct Data Capture (DDC)
  • Randomization with EDC 
• Case Study - Cholera vaccine study in Yemen
  • Collecting clinical data without an internet connection
  • The downside of paper data collection
• DDC is a subset of eSource
• eSource can be EHR, DDC, ePRO, eCOA
• Future of EDC as we get more integrated with EHR
• Patient recruitment
  • New efforts through AI
  • Efforts through social media
  • Genetic profiling
• Enabling participants to be anywhere in the world to participate in the trial
• Barriers to adoption
• Importance of monitoring in a virtual clinical trial to prevent fraud 
• The downside of a virtual clinical trial is the implementation
  • Patients want their doctor to be involved
  • New tools lead to new complications
  • The trial does not match the decentralized model
• Common concerns from Sponsors
  • Storing data on the cloud is risky
  • Offline data management - what if the wifi goes down or there is no cellular signal
  • Data loss - what if the tablet break
• Thinking in terms of relative risk
• Clinical trials fail 90% of the time
• Trial data is never looked at again
• Need to standardize audits to bring the cost down and improving the quality of the audit
• Medrio is focused on: 
  • Speed
  • Great tool for early phase diagnostic and device studies
  • Customer service measured using net promoter scores
  • eSource - Direct Data Capture (DDC)
• Optimism, focusing on the positive, not watching/ reading the news

Medical Imaging in Clinical Trials with Elizabeth Dalton

In this episode, I’m excited to talk about medical imaging in clinical trials. 

We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more.

The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.  

Liz is a seasoned clinical trial professional with 17+ years of experience working with sponsors, sites, and CROs in centralized medical imaging and clinical trials.

Driven by a passion for service, Liz’s ethos is rooted in honesty, productivity, commitment, and the power of positive energy. 

In addition to her primary role of growing the Calyx partnership/CRO channel, Liz leads a team of technical solution consultants and is a medical imaging consultant herself. 

Liz attended the University of Massachusetts where she achieved dual Bachelor degrees in Anthropology and Economics (magna cum laude) and will graduate in May 2023 with her MBA from Boston University’s Questrom School of Business. 

Please join me in welcoming Liz on the Clinical Trial Podcast. 

This episode is brought to you by Calyx. To learn more about Calyx, please visit https://www.calyx.ai/ 

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases.

There are no certification or degree requirements to work as a clinical research professional either.

To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast.

Erika advises life sciences, academic medical centers, hospitals, cancer centers, foundations and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance. 

She has over 20 years of research/ R&D experience, serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. 

Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University.  She also holds a Graduate Certificate in Gerontology from Case Western University.

Please join me in welcoming Erika on the show.

Podcast Sponsor(s):

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Slope is trusted by industry leaders in complex early-phase clinical trials from top 50 pharma and CROs to emerging biotechs, and a global site network including NCI cancer centers and AMCs. Learn more at https://www.slopeclinical.com/

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

 

In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more.

Hope you enjoy my interview with the all amazing Norman Goldfarb.

About Norman Goldfarb

Norman Goldfarb is a seasoned executive and leading authority on clinical research best practices. He has authored or presented hundreds of articles and talks on clinical research. He is Managing Director of First Clinical Research, Editor of the Journal of Clinical Research Best Practices, and Chairman of MAGI.

Show Notes:

• Norm’s transition from high tech to clinical research via his work on a patient recruitment software [01:53]
• Why clinical research site business is a hard business [04:28]
• The career path of site principal investigators [06:20]
• Advice for recent graduates in the field of medicine  [10:30]
• Challenges of being a study coordinator and how to overcome them [12:15]
• Pros and cons of remote monitoring [15:45]
• Importance of standardization in research [20:03]
• Model Clinical Trial Agreement Template [23:35]
• Resources of study coordinators negotiating clinical trial agreements [24:55]
• Ben Franklin [28:01]
• On writing controversial articles in clinical research  [29:45]
• Certification in clinical research and does it matter [31:01]
• On negotiation  [36:04]
• Two-year requirement for taking certification exams and what matters most in clinical research [40:25]
• High road marketing [49:31]
• Philosopher's Stone [53:29]
• Why should someone be in clinical research in the first place? [56:57]

 

  “We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data.  Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry. Hope you enjoy my interview with the all amazing Manuel Prado.

About Manuel Prado

Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year’s sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home. Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.In 2010, Manuel Prado began to transition away from the daily management of VIVA and founded RealHealthData, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world. Prado is also the founder of Adhearx, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence.

About This Podcast Episode

Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

• Connect with Manuel Prado on LinkedIn
• The Center for Information and Study on Clinical Research Participation  (CISCRP)
• The New England Journal of Medicine
• Kevin Kelly & The Inevitable
• Brene Brown
• 750 Words
• 5 Minute Journal
• Fierce Pharma
• Fierce CRO
• Fierce Biotech
• Fierce Medtech
• Center Watch
• Modern Medicine
• PM360
• Pharmaceutical Executive
• Real Health Data
• Adhearx

Show Notes:

• Manuel’s journey into clinical research [01:48]
• Medical transcription and the problem RealHealthData is trying to solve [05:34]
• Analyzing claims and EMR data and how it’s impacting recruitment in clinical trials [08:57]
• What physicians are looking at when making referrals to specialists  [10:54]How clinical data companies can engage with sponsors [19:00]
• FDA and real-world data [27:52]
• Impact of real-world data on clinical roles [30:09]
• The pace of change in life science industry [35:52]
• Why you should consider journaling [43:17]
• Sabbatical and surfing [48:17]
• Passion and life philosophy  [53:17]
• Where is reliable data coming from and what clinical researchers should focus on [55:29]
• Morning routine, staying focused and not getting distracted  [59:17]
• Making mistakes and not failure [1:00:52]
• Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.  

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division.

She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data.  

Her work focuses on the use of electronic health record systems and claims data for research, with a focus in study design methodology, maternal health, orthopedics, oncology, and infectious disease.  

Dr. Mack oversees development of large evidence hubs and novel studies that augment primary data collection with existing data and leads the IQVIA Injury Surveillance and Analytics team which serves as the epidemiologic research arm of the NFL and NBA.

She is an epidemiologist and computer engineer by training, with Ph.D. and master’s degrees from the University of North Carolina at Chapel Hill and an engineering degree from the University of Notre Dame.  

Currently, Dr. Mack holds an academic appointment as Adjunct Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill and serves on the Advisory Board of the Carolina Health Informatics Program.

Dr. Mack has published manuscripts in leading journals and authored several chapters in the Agency for Healthcare Research and Quality (AHRQ) landmark publication "Registries for Evaluating Patient Outcomes: A User's Guide" on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks.  

She is a speaker at regulatory, governmental, and academic forums on epidemiologic methods and novel study designs as well as careers in research.

Last but not the least, she has over fifteen years of scientific and technical experience working for Johnson & Johnson, GlaxoSmithKline, IBM, and the World Health Organization in addition to her work at IQVIA. Her regulatory experience includes advising the FDA, most recently as faculty at the 2017 MDEpiNet Annual Meeting and at the FDA Cardiac Research Safety Consortium discussing novel research methods and use of electronic medical records for outcomes trials.  

Please join me in welcoming Dr. Mack on the Clinical Trial Podcast.

Resources and organizations mentioned in this episode:

IQVIA

Food and Drug Administration (FDA)

Pubmed

ClinicalTrials.Gov

Norwegian Mother and Child Cohort Study (MoBa)

Global Fund

Clinton Foundation

World Health Organization and HIV

IBM

Johnson and Johnson

Organization of Eastern Caribbean Islands

Outcomes Sciences

MIT

Harvard School of Public Health

University of Lusaka

Quintiles

Healthcare Business Women's Association

Agency for Healthcare Research and Quality (AHRQ) landmark publication “Registries for Evaluating Patient Outcomes: A User’s Guide” on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks

American College of Cardiology

National Cancer Institute

FDA's Sentinel Initiative

NBA

NFL

MDEpinet

University of North Carolina Chapel Hill

New York Times

People mentioned in this episode:

Manuel Prado

Dr. Nancy Dreyer

Dr. Mark Travis

Rob Cahill

I’m always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion.

Our guest on today’s show is Maya Zlatanova, CEO of FindMeCure. 

Maya and her team are creating a “google” for clinical trials. 

• She is on a mission to make it easy for patients to find ongoing clinical trials
• She wants to solve patient recruitment challenges enabling patients and doctors to connect with each other
• She believes in the power of stories, not just facts, something unheard of (but much needed) in clinical research.

FindMeCure is dedicated to simplifying the patients' journey while volunteering for a clinical trial while helping the industry plan their trials with the full picture of country capacity, sites' experience and patients needs and journey.

Maya is a healthtech entrepreneur, clinical research expert, and pharma industry speaker with over 15 years of global experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations. 

Maya’s strongest skill is empathy. 

Her principles in life are to be trustworthy, care for other people and give first. 

She also cherishes her never-ending curiosity about how life and the universe work, how to improve ourselves and our environment. 

Please join me in welcoming Maya Zlatanova on the Clinical Trial Podcast.

[2:25] About Maya’s company FindMeCure, Maya’s experience working on clinical research software for the British government and first online GCP training

[4:14] Maya’s sister was diagnosed with an eating disorder and struggled to find treatment. This let to Maya looking at clinical trials from a patient perspective

[6:06] Creating a global platform for patients to find out about alternative treatments in clinical trial setting

[8:29] Connecting patients in one country with clinical trials in another country

[9:55] Challenges for patients include:

• Human factors such as need to be close to family
• Traveling long distances to participate in clinical trials
• Being treated by different doctor (trial investigator) than their primary physician 

[13:01] Patient recruitment process can benefit from change. Currently we first select sites and then bring patients into these sites

[14:26] We need to break things to innovate

[15:25] In an ideal world, we would have a centralized electronic health record, we know where patients are, patients are monitored with telehealth solutions, central site that is leading other sites 

[16:55] Everyone wants to go to the experienced sites

[19:43] Hybrid clinical trials

[20:28] Need to support sites and investigators by questioning what sites should and shouldn’t do

[24:05] convincing decision makers to select sites in other geographies using financial metrics

[28:03] Language is not an obstacle at most sites. Ethical considerations can pose an issue. 

• CRO with local office 
• Site Management Organization (SMO)
• Own CRA networks

[32:00] Adoption of technology in clinical research such as sites being open to new remote solutions

[33:35] Whatever works for clinical research will work for the healthcare sector

[34:03] ACRES helping sites getting accredited and certified if they follow certain standards for clinical trials

[36:32] GCP is the only standard in clinical research. For example, it is not sufficient for patient centric trials

[38:02] Need to align on initiatives such as patient engagement guidelines in EU and USA

[39:45] Empathy is a feeling for people and imagining yourself in their shoes. Being open to the fact that you could be wrong. Listening to people, hearing you are wrong, and converting to the right thing

[42:42] Maya’s secret weapon is speaking with different people with different backgrounds to learn and grow

Resources mentioned:

Society of Clinical Research Sites (SCRS)

Association of Clinical Research Professionals (ACRP)

Food and Drug Administration (FDA)

Alliance for Clinical Research Excellence and Safety (ACRES)

TransCelerate - Pharmaceutical Research and Development

Pharmaceuticals and Medical Devices Agency (PMDA)

EUPATI: Patient Engagement Through Education - EUPATI

 

The pandemic has helped fast track the adoption of technology in clinical research.

This has been a much needed change and we’re headed in the right direction. 

The change in turn has led to an increased focus on decentralized clinical trials (DCTs). 

But what exactly is a DCT? 

To learn more, I invited Derk Arts, Founder & CEO of Castor. 

Derk has over fifteen years of experience in medicine, research and technology. 

His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials. 

What is great about Derk is that he is a physician by training and now runs a clinical trial software company. 

At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting. 

At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems. 

This was a fun interview for many reasons. 

Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more. 

I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast.

This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.

 

There are advantages and disadvantages when it comes to being a standalone clinical trial site. 

Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial. 

This is where site networks come in. 

For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network.

To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show.

Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research. 

Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials. 

With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally. 

His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem. 

A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa.

Enjoy!

Sponsors:

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

 

A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run.  To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.   Kristi founded Clinical Research Billing in 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly seven years, she and her partners have built Clinical Research Billing into a successful, growing small business.

Kristi served as Chief Executive Officer of Atlantic Clinical Research Collaborative in Palm Beach County, Florida, where she oversaw the implementation of a clinical trial management system. 

Kristi is an experienced corporate executive with a background in corporate finance and international equity markets. 

Kristi received her M.B.A. in finance from The Wharton School at the University of Pennsylvania, B.A. in economics and psychology from Pitzer College, Claremont, California, and the Chartered Financial Analyst designation from the CFA Institute. 

She studied pharmaceutical law at Seton Hall University.

Please join me in welcoming Kristi on the show.

This poodast is brought to you by Florence Healthcare. To learn more, please visit https://florencehc.com/.

 

In this interview, I had the pleasure of speaking with Stephen Smith. Stephen has several years of project management experience in the healthcare industry. His experience isn’t limited to clinical project management. Stephen has served as senior program management director where was the glue between R&D, marketing, clinical and manufacturing teams for rare disease and oncology drugs. Stephen shares his experience working for top-notch organizations such as Genentech, Gilead Sciences, Audentes Therapeutics and more. Since the time we recorded this interview, Stephen has changed employers. However, our discussion of challenges with clinical trials for rare diseases, the process for career development and importance lifelong learning still holds true. In this interview, Stephen and I discuss why communicating clearly is important and how being humble and calm can make you a super-star. There is a wealth of information on people skills that all of us need to hone and develop in order to accelerate our clinical research career. Please join me in welcoming the all-amazing Stephen Smith to the Clinical Trial Podcast.

Do you want to enroll a diverse patient population in your clinical trial? 

Are you a sponsor looking to develop a solid clinical trial strategy?

Are you looking to develop foundational skills as a clinical research scientist?

If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well.

Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices. 

She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations. 

It’s because of Jenn’s direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance. 

Most recently, Jenn has been involved in Abbott’s efforts in designing studies that include a diverse group of underserved clinical trial participants. 

As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research. 

My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more.

I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.

“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clinical studies and has been an integral part of the growth of GCP Research. Gabriel graduated from Concordia University with a BSc and a Specialization in Biology. He has also finished a follow-up Graduate Diploma program in Health Care Management from McGill University.Please join me in this fun and insightful conversation with Gabriel D’Amico-MazzaAbout This Podcast Episode Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode

• Connect with Gabriel D'Amico-Mazza on LinkedIn
• GCP Research
• Facebook Blueprint
• Health Canada
• Vantage Biotrials
• Clinical Research Association of Canada
• Association of Clinical Research Professionals
• Society of Clinical Research Associates

Show Notes:

• Business development for clinical trials [01:06]
• Recruiting participants, why people want to be in clinical trials [02:36]
• The composition of a small site in clinical research [11:05]
• Process for building relationships with a network of doctors and specialists [13:20]
• Three things that motivate physicians  [16:50]
• How doctors get paid in a hospital setting [20:04]
• Average bill rate for a general practitioner in Canada [21:16]
• Gabriel's journey from college to clinical research [24:02]
• Working with Quebec sites if you are a sponsor or CRO personnel from another country [28:00]
• Social media marketing to recruit trial patients [32:00]
• Key Performance Indicators (KPIs) at GCP Research [45:20]
• How to get feedback to improve clinical trial conduct [52:05]
• Attending clinical research conference [56:28]
• Email vs. calling people and why picking up the phone makes a difference [59:55]

What was your favorite part of this interview? Let me know in the comments section below.