Clinical Trial Podcast | Conversations with Clinical Research Experts
This podcast focuses on clinical research and trial management, featuring conversations with industry experts. It covers topics relevant to sponsors, CROs, and clinical trial sites. Aimed at current and aspiring clinical research professionals, including CRAs, study managers, and biostatisticians. The show provides insights to build and advance careers in clinical research.
Episodes
How Statisticians Really Think About Endpoints, Power, and FDA Review with Roseann White
Statistics influence almost every major decision in a clinical trial. In this episode, Roseann White, a retired biostatistician with more than 30 years of experience, joins the Clinical Trial Podcast to make biostatistics practical for clinical research professionals. Roseann explains what statistical significance really means, why clinical meaning matters, how to think about superiority and non-i
How Clinical Research Hiring Decisions Are Actually Made with Giovanni Lauricella
Why do qualified candidates apply to role after role in clinical research and never hear back? In this episode of the Clinical Trial Podcast, we unpack what's really happening behind the scenes in the hiring process. Getting hired isn't just about your technical skills. It's about how hiring managers assess risk, how recruiters decide who to champion, and who actually gets attention versus who get
Designing and Conducting Observational Studies with Thomas Newman, MD, MPH
What separates strong clinical research from misleading conclusions? Often, it comes down to study design. In this episode of the Clinical Trial Podcast, Kunal Sampat sits down with Dr. Thomas Newman, Professor of Epidemiology and Biostatistics at UCSF and co-author of Designing Clinical Research, to break down how observational studies actually work. While randomized controlled trials are often c
Cardiovascular Device Development: From Idea to Reality
Bringing a high-risk cardiovascular device from concept to patient care requires more than innovation - it requires carefully designed clinical trials, strong operational execution, and close collaboration with regulators and physician investigators. In this episode of the Clinical Trial Podcast, Kunal Sampat speaks with Nicole Haratani about how cardiovascular device clinical trials are actually
Best Practices for Clinical Trial Budgeting
Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites. In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—an
Risk Based Monitoring in Clinical Trials with Artem Andrianov
Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way. In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today's
Leading a Clinical Research Organization in the European Union with Dr. Philip Raeth
In this episode of the Clinical Trial Podcast, host Kunal Sampat sits down with Dr. Philip Räth, Managing Director of Palleos Healthcare, to discuss leading Clinical Research Organization (CRO) in the European Union (EU). Managing a Clinical Research Organization is far more than project oversight. CRO leaders juggle sponsor expectations, site relationships, internal talent, regulatory demands, an
Sponsor, Site, and Technology Vendor Collaboration with Mike Wenger
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 develo
Inspection Readiness with Donna Dorozinsky
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 pharmace
Clinical Trials in Saudi Arabia with Dr. Majed Al Jeraisy
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 Universi
Cardiology Clinical Trials with Dr. Gregg Stone
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 h
Clinical Trial Insurance with Dan Fuld
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 implementat
Diabetes Clinical Trials with Dr. Stayce Beck
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 Adminis
Access to Novel Medical Products with Dr. Alison Bateman-House
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-Ho
Clinical Research as a Profession with Erika Stevens
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 medica
Community Engagement in Clinical Trials with Chris Komelasky
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
Community health system-based research with JoAnne Levy
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 organizatio
Postmarket Surveillance Studies with David Rutledge
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 a
Human-centered design role in clinical trials with Bruce Hellman and Ben James
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 complete
Clinical Trial Site Networks with Christian Burns
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
Heart Failure Clinical Trials with Sonna Patel-Raman
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 f
Medical Imaging for Clinical Trial Sites with Kelie Luby
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
Risk Management for Clinical Investigators with Bijan Elahi
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 i
5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat
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 thes
Clinical Trial Outsourcing with Anca Copaescu
Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
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 co
Patient Recruitment in Phase I Studies with Dr. Graham Wood
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 p
Medical Imaging in Clinical Trials with Elizabeth Dalton
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 t
Clinical Research Data Transparency with Darshan Kulkarni
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
Launching an NIH Funded Study with Dr. Manish Shah
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
Introduction to Coverage Analysis with Kelly Willenberg
Clinical Data Management with Mariam Mirgoli
There is more to the world of clinical data management than building and cleaning databases. Did you know you can leverage your clinical data for clinical operational excellence across your organization? To educate us on the nuts and bolts of clinical data management and how data can guide us with our clinical operations decision making, I invited Mariam Mirgoli, Vice President of Clinical Data M
Clinical Research Billing for Small to Medium Sites with Kristi Etchberger
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
Integrating EHR and EDC Systems with Hugh Levaux
One of the most time and resource intensive tasks in clinical research is data entry. Clinical research coordinators spend countless hours transferring clinical data from a patient's Electronic Health Record (EHR) into a study specific Electronic Data Capture (EDC) system. This is annoying because the research coordinator could instead spend those hours on recruiting patients. A direct EHR to E
Software Solutions for Clinical Research Sites with Ryan Jones
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
Diversity, Inclusion, and Equity in Clinical Research with Barbara Bierer, M.D.
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 i
Patient Recruitment Failure in Clinical Trials
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 c
Regulatory Affairs for Medical Device Clinical Trials with Priya Jagasia
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 Vi
Decentralized Clinical Trials with Derk Arts
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, res
Psychedelic Clinical Trials with Rebecca Matthews
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 (PT
Diversity and Inclusion in Clinical Trials with Jennifer Jones-McMeans, Ph.D.
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 cardi
Clinical Trial Readiness with Joel Selzer
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 re
Clinical Research Soft Skills with Ed Hogan
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,
Patient Support Programs in Middle East and North Africa (MENA) with Maha Dakhloul
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 a
Career Development in Clinical Research with Chris Lewis
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 an
Solving Patient Recruitment Challenges with Maya Zlatanova
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 doctor
Patient Centricity in Clinical Trials with Craig Lipset
Managing and Communicating Clinical Trial Finances with Blake Peters
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 w
Virtual Clinical Trials with Mike Novotny
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 foundi
Conducting Clinical Research in Egypt with Ahmed Hamouda
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 se
Role of Field Clinical Engineer (FCE) in Medical Devices with Ravi Shankar
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.
Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem
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 re
Clinical Research In New Zealand
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 surgeo
Clinical Project Management with Antoinette (Torres) Frankum
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
Getting Intro Research and CRO Partnerships with Jessie Coe
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 pro
17 Strategies to Increase Patient Recruitment in Clinical Trials
Managing Clinical Inventory with Rust Felix and Joy Jurnack
Genetic Testing in Clinical Trials with Karmen Trzupek
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 b
The Ultimate Roadmap for Patient Recruitment
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 med
Bioethics in Clinical Research with Dr. Lindsay McNair
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 ethica
Real-World Insights and Epidemiology with Dr. Christina Mack
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 fo
The World of Program Management with Stephen Smith
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 shar
Become an Outstanding Clinical Researcher with Dr. Jeff Kingsley
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 C
Solving Clinical Research Problems Using Technology with Ryan Jones
"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 intervi
From Disney to Drugs with Melissa Easy, Founder of DrugDev
"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
CTP 011: From Disney to Drugs with Melissa Easy, Founder of DrugDev
Technology makes our lives easier, but it doesn't replace people.
Effective Clinical Research Sites with Gabriel D'Amico-Mazza
"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 recruit
Real World Data in Clinical Trials with Manuel Prado
"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 p
Exceptional Clinical Research Insights with Norman Goldfarb
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
The Future with EMR with Dr. Manfred Stapff
"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 a
Journey from Engineer to Clinical Director with Robin Eckert
"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 cl
Health Economics and Outcomes Research with James Hasegawa
"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
13 Suggestions for Becoming a Great Clinical Project Manager
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 epi
Conversation with Clinical Development Veteran Marshall Cool
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
Hidden Opportunities in Clinical Research with Gary Thompson
"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 fre
Becoming an Intelligent Clinical Researcher with David Rutledge
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) an
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