Clinical Trial Podcast | Conversations with Clinical Research Experts

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 considered the gold standard, observational studies are essential in many real-world settings. But they come with challenges including bias, confounding, and misinterpretation that can lead to flawed conclusions if not handled correctly. Dr. Newman shares a practical framework to help you design better studies, interpret results more critically, and build a stronger foundation in clinical research. In this episode, you'll learn: When observational studies are more appropriate than randomized trials A practical framework for designing observational research Key threats to validity: bias, confounding, and chance How to interpret associations vs. causal effects Strategies for dealing with confounders in analysis How to approach statistics with more clarity and confidence About the guest: Dr. Thomas Newman, MD, MPH, is a Professor of Epidemiology and Biostatistics at the University of California, San Francisco. His work focuses on applying epidemiologic methods to important clinical problems in child health, including neonatal jaundice, infections in newborns, and cholesterol screening. He is widely recognized for his contributions to clinical research education and is co-author of Designing Clinical Research and Evidence-Based Diagnosis. Why this episode matters: If you want to grow in clinical research, you need more than surface-level knowledge - you need to understand how studies are designed and where they can go wrong. This episode helps you think like a clinical researcher.

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 designed and run. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in medical device clinical research, particularly in cardiovascular technologies. Nicole shares insights from her experience leading clinical and regulatory programs across feasibility and pivotal trials, and explains the operational realities behind Class III device studies. In this episode, we discuss: How cardiovascular devices move from concept to clinical trials Designing feasibility and pivotal trials for Class III devices How inclusion and exclusion criteria are developed Challenges in patient recruitment for cardiovascular studies Collaborating with key opinion leaders and investigators Working with the FDA during the PMA process Career advice for professionals interested in medical device clinical research If you're interested in cardiovascular device development, clinical trial operations, or building a career in medical device research, this episode provides a practical look at how complex device trials are executed.

Matt Lurie, consultant advising sites on budget negotiations and sustainability. Heidi Kassel, site business lead focused on operations and billing compliance. Kristen McKenna, Pfizer contracts lead overseeing global site budgeting. They discuss why budgets stall, what makes defensible justifications, templates and fee schedules, communication tactics, and ways sponsors and sites can speed negotiations.

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 regulatory landscape. Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management in clinical trials. Together, they explore how the industry has evolved from traditional monitoring approaches to a more holistic model centered on risk-based quality management and quality by design. Dr. Andrianov shares practical insights on common misconceptions, why simply reducing monitoring is not a strategy, and how technology and analytics can be used to proactively manage risk. The conversation also examines the changing role of CRAs, and the growing expectations from regulators and inspectors.

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, and profitability. A strong CRO partner can jumpstart a clinical trial for industry or academic sponsors that have limited infrastructure. A mismatched CRO, on the other hand, can derail timelines, add cost, and create friction you don't need. About Today's Guest: Dr. Philip Räth Dr. Räth brings 15 years of experience in the medical product industry and currently leads Palleos Healthcare, a central European full-service CRO supporting pre-clinical consulting through large-scale clinical trials. Operations in 19 countries 336+ projects delivered Expertise across 23 therapeutic areas In this episode, you'll learn: What makes a CRO truly sponsor-ready Where CRO selection often goes wrong How digital transformation and AI are reshaping CRO operations Insights from Palleos' work across Europe and diverse therapeutic areas The future of full-service clinical trials from a CRO leader's perspective

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 collects data directly at the point of patient interaction to lighten site burden while driving protocol compliance. Please join me in welcoming Mike on the Clinical Trial Podcast. 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 37,000 study sites, sponsors, and CROs in 90 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/

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 Readiness, and Trial Master File (TMF) Management. She is the Lead Editor in the newest edition of Good Clinical Practice: A Question and Answer Guide 2024/2025, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year. Donna earned a Bachelor of Science in Nursing from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and a Master of Science in Nursing from Widener University. 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 37,000 study sites, sponsors, and CROs in 90 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/

Dr. Majed Al Jeraisy, an Associate Professor at King Saud Ben Abdulaziz University for Health Sciences, shares valuable insights about clinical trials in Saudi Arabia. He highlights the country's modern healthcare system and the diverse patient pool as key advantages. The conversation dives into regulatory challenges, especially in recruitment and data integrity. Dr. Al Jeraisy also discusses the vital role of research coordinators and the need for better training and resources to improve local clinical research practices.

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

Dan Fuld, a seasoned insurance professional with over a decade of experience in underwriting and broking, dives into the essential role of insurance in clinical trials. He discusses the various types of insurance necessary to protect participants and sponsors, emphasizing the nuances of vicarious liability and tailored risk management strategies. Dan also highlights the importance of selecting the right insurance partner and sheds light on international insurance requirements. Listeners gain insights on safeguarding trial participants and mitigating legal risks.