Clinical Trial Podcast | Conversations with Clinical Research Experts

To get more insights about clinical research technology from a vendor's perspective, I invited Mike Wenger on the Clinical Trial Podcast.

Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research. 

At the Michael J. Fox Foundation for Parkinson's Research, he worked to connect Parkinson's patients with clinical studies. 

He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows. 

Mike is currently the Chief Innovation Officer at CRIO, an intuitive eSource solution that col...

To discuss what inspection readiness entails, I invited Donna Dorozinsky, Founder & CEO of Just in Time GCP to the show.   Donna is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.    

Her vast experiences dealing with small to large pharmaceutical companies, academic centers, regulatory agencies, clinical research organizations, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance.  

Donna has presented training programs in topics of GCP compliance, Quality Management Systems, Inspection Readin...

Saudi Arabia's modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show.  

Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, College of Pharmacy, King Saud Ben Abdulaziz University for Health Sciences and Pediatric Clinical Pharmacy Consultant in King Abdullah Specialized Children Hospital. He was appointed as the chairman of the research office at King Abdullah International Medical Research Center (KAIMRC) in 2007 and was appointed as the Di...

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 i...

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<...

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. B...

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, go...

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...

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 a...

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 in...

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 i...

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 T...

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 Ell...

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...

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 im...

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 mo...

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 fo...

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. C...

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...

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 CRO...

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...

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...

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 year...

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 m...

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 th...

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.

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 a...

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...

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...

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 de...

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 A...

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 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...

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...

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.

FindMeCure is dedicated...

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...

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 m...

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...

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...

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 press...

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...

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 ta...

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...

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...

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...

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...

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...

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...

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...

"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...

"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...

"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...

"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...

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...

"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...

"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...

"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...

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...

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...

"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...

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"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...