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 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.

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/​.

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/

Erika Stevens, an expert in clinical research process improvement, discusses the lack of defined roles and certifications in clinical research. The podcast explores initiatives to standardize the field, online training modules, the importance of clinical trial offices, and acquiring skills and hands-on experience in the profession.

Chris Komelasky, CEO and Co-founder of SiteBridge Research, discusses community engagement in clinical trials, building relationships, health literacy, technology for patient recruitment, identifying community sources, public benefit corporations, FDA regulations, decentralized trials, patient compensation, and resources for community engagement.

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