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 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/

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 Director of Clinical Trial Services in 2018.  Please join me in welcoming Professor Majed Al Jeraisy on the Clinical Trial Podcast. This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/ This podcast is brought to you by 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 

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

In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and Enjoy! Sponsor(s): This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​  

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/

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast. Erika advises life sciences, academic medical centers, hospitals, cancer centers, foundations and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance.  She has over 20 years of research/ R&D experience, serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations.  Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University.  She also holds a Graduate Certificate in Gerontology from Case Western University. Please join me in welcoming Erika on the show. Podcast Sponsor(s): This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Slope is trusted by industry leaders in complex early-phase clinical trials from top 50 pharma and CROs to emerging biotechs, and a global site network including NCI cancer centers and AMCs. Learn more at https://www.slopeclinical.com/ This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.