Shows
Clinical Data TalksBeyond the data: Human stories from clinical trials in UkraineIn this final episode of season 2, Sylvain Berthelot welcomes Anna Titkova, who shares her first-hand experience of running clinical trials in Ukraine before and during the conflict. In 2022, Anna lived in Ukraine and acted as the country head for Pratia, a research site network.Anna describes how Ukraine, once a thriving hub for international clinical research, was suddenly forced to adapt to unprecedented challenges. From halting patient recruitment and struggling with the shipment of investigational medicines, to relocating vulnerable oncology patients across borders, she paints a vivid picture of resilience and resourcefulness under pressure.Together...
2025-11-2629 min
Clinical Data TalksThe impact of geopolitics in clinical trial location with Scott SchliebnerIn this episode, Sylvain Berthelot welcomes Scott Schliebner, Global Head of Drug Development Consulting at Novotech. With over 25 years of experience across CRO leadership roles, Scott brings a unique perspective on how global politics and shifting market dynamics are influencing where – and how – clinical trials are run.Together, Sylvain and Scott explore the growing uncertainty created by political change, regulatory shifts, and economic pressures, and how these factors are shaping sponsor strategies. From the rise of early-phase studies in Australia and New Zealand, to the diversification of phase III trial geographies, they discuss why sponsors are increasingly relu...
2025-11-1224 min
Clinical Data TalksStriking the right balance between risk and innovation with Marek WasilukSylvain Berthelot welcomes Dr. Marek Wasiluk, CEO of ClinMark. With a career that spans from CRA to leading a global CRO, Marek brings a unique perspective on how clinical research organizations can embrace innovation while safeguarding trial quality.Together, they explore the fine balance between adopting new technologies and managing operational risk. Marek shares how his background in medicine, quality assurance, and clinical operations shapes his approach to implementing digital solutions that not only meet regulatory expectations but also bring real value to sponsors and patients.Sylvain and Marek discuss why CROs must be both...
2025-10-2930 min
Clinical Data TalksLeveraging eSource in clinical data collection with Mats SundgrenJoin Sylvain Berthelot as he welcomes Mats Sundgren, Senior Advisor at the European Institute for Innovation through Health Data. A pioneer in implementing eSource during his years at AstraZeneca, Mats shares how this approach is transforming clinical research.Together, they explore what eSource really means and why reducing duplicate data entry at site level is such a game-changer. Mats highlights findings from a recent study with Memorial Sloan Kettering Cancer Center, which revealed the heavy time burden manual data entry places on coordinators, and how eSource can dramatically improve efficiency and data quality.The discussion...
2025-10-1529 min
Clinical Data TalksGoing paper-free in early phase trials with Joe EratoSylvain Berthelot sits down with Joe Erato, Chief Operations Officer at Spaulding Clinical. Together, they explore what it really takes to run early phase studies without paper – and why the transition to fully electronic systems can be both challenging and transformative.Joe shares how Spaulding Clinical was founded with a vision to “take clinical research into the next generation using technology,” and what it meant to implement paper-free processes from the very beginning. He reflects on the steep learning curve, the risks of being first to adopt, and the operational upheaval required to shift an entire unit away f...
2025-10-0126 min
Clinical Data TalksMaking data surveillance a reality with Tanya Du PlessisIn this episode of Clinical Data Talks, Sylvain Berthelot welcomes Tanya Du Plessis, Chief Data Strategist and Solutions Officer at Bioforum. Together, they unpack what data surveillance really means and how to make it a practical reality in today’s clinical trials.With over two decades of experience in clinical data management, Tanya shares how the evolving regulatory landscape – including ICH E8 and ICH E6(R3) – is pushing sponsors to adopt a more holistic, risk-based view of data. Rather than reacting to problems at the end of a study, she explains how data surveillance empowers teams to identif...
2025-09-1729 min
Clinical Data TalksApplying real world evidence to clinical trials with Cristina Chang test 1Applying real world evidence to clinical trials with Cristina Chang
In the final episode of season 1, Sylvain Berthelot welcomes Dr. Cristina Chang, Chief Medical Officer at HiRO, to unpack the growing importance of real-world evidence (RWE) in clinical development.
With decades of experience across global pharmaceutical companies, Cristina shares her deep insights into how real-world data is being applied to clinical trials to enhance patient outcomes, regulatory submissions, and post-marketing strategies. She discusses the practical considerations for using RWE, from data collection challenges to ensuring scientific rigor, as well as how the regulatory landscape is...
2025-08-0426 min
Clinical Data TalksApplying real world evidence to clinical trials with Cristina ChangApplying real world evidence to clinical trials with Cristina ChangIn the final episode of season 1, Sylvain Berthelot welcomes Dr. Cristina Chang, Chief Medical Officer at HiRO, to unpack the growing importance of real-world evidence (RWE) in clinical development.With decades of experience across global pharmaceutical companies, Cristina shares her deep insights into how real-world data is being applied to clinical trials to enhance patient outcomes, regulatory submissions, and post-marketing strategies. She discusses the practical considerations for using RWE, from data collection challenges to ensuring scientific rigor, as well as how the regulatory landscape is...
2025-06-0426 min
Clinical Data TalksRealising the true benefits of risk management with Brian BarnesIn this episode of Clinical Data Talks, Sylvain Berthelot welcomes Brian Barnes, Director of Risk Management Strategy at BioNTech, to explore the human and strategic dimensions of risk-based quality management (RBQM).Drawing from his rich experience across CROs, technology vendors, and now a sponsor organisation, Brian shares how his role as a “risk assessment facilitator” reflects a broader cultural shift: developing a company-wide risk-focused mindset and moving risk management upstream into study design and operational planning.Sylvain and Brian talk about building risk frameworks from the ground up, demonstrating return on investment for RBQM and conf...
2025-05-2122 min
Clinical Data TalksA new way of defining clinical endpoints with Sebastien CoppeJoin host Sylvain Berthelot and Sébastien Coppe, CEO and co-founder of One2Treat, to explore a patient-focused approach to redefining clinical endpoints. Drawing from his background in optimizing clinical supply chains and his passion for involving patients more deeply in trial design, Sébastien shares how One2Treat is using technology to bring the patient’s voice into the earliest stages of clinical development.The discussion touches on the limitations of traditional endpoints, the value of co-designing studies with patients, and the promise of tools that capture lived experiences to define outcomes that truly matter. Sébasti...
2025-05-0727 min
Clinical Data TalksThe future of technology and AI in clinical trials with Joe DustinIn this episode of Clinical Data Talks, host Sylvain Berthelot welcomes industry veteran Joe Dustin to explore the evolving landscape of eClinical technology and the impact of AI in clinical trials. With decades of experience across eClinical vendors and the sponsor side, Joe shares his insights into the major transformations shaping the industry - from paper-based processes to electronic data capture, on-premise systems to cloud platforms, and now, the rise of AI-driven solutions.Together, they discuss the current challenges of interoperability and fragmentation in clinical data, the potential of AI to enhance data management and trial design...
2025-04-2326 min
Clinical Data TalksThe evolving role of data managers with Kelly ForesterThe evolving role of data managers with Kelly ForesterSylvain Berthelot sits down with Kelly Forester, a clinical data management expert with 30 years’ experience. Kelly shares personal stories from her journey in clinical research, including how she transitioned from early roles in data entry to leading global data strategies.They both reflect on the shifting expectations for data managers, from scripted technical execution to strategic thinking. In an increasingly digital and decentralized clinical trial landscape, they discuss the need for adaptability as ever evolving technologies reshape the industry.The conversation also dives into ca...
2025-04-0924 min
Clinical Data TalksThe challenges and promises of the clinical data lifecycle with Doug BainFor the first episode of Clinical Data Talks, host Sylvain Berthelot welcomes industry expert Doug Bain to explore the intricate journey of clinical data - from its initial collection to final submission. With a background spanning software development and leadership roles at eClinical vendors and CRO, Doug brings a wealth of experience and sharp industry insights.Together, they discuss the evolving challenges of managing clinical data efficiently, the impact of new technologies on data workflows, and the importance of standardization in the world of clinical data. Doug also shares his perspective on how the industry can address...
2025-03-2631 min