Clinical Data Talks

Sylvain Berthelot welcomes Claudia Rodriguez, CEO of RARAS, a CRO specialized in conducting research across Latin America. Together, they explore the untapped potential of this diverse region and why it is increasingly becoming a strategic priority for global sponsors. With a deep passion for the Latin American market, Claudia dispels common myths about the region’s accessibility and infrastructur...

In this episode of Clinical Data Talks , Sylvain Berthelot welcomes Dr. Kavita Gaadhe, a clinical data management lead working at the high-stakes intersection of technology and precision medicine. Together, they explore the increasingly complex reality of managing non-linear data flows in a digitalized landscape. With expertise in navigating the "data mesh" of modern trials, Kavita shares how data...

In this episode of Clinical Data Talks , Sylvain Berthelot welcomes Ella Balasa , a patient advocate and leading voice in shaping collaborative approaches to clinical research. Together, they explore the critical importance of embedding the patient voice into every stage of the clinical trial lifecycle to ensure research is truly inclusive and effective. With a deep personal history of navigating...

Sylvain Berthelot welcomes Jennifer Stewart, Vice President AI and Innovation at Premier Research and an active member of ACRO’s Risk-Based Quality Management (RBQM) working group. Together, they explore the current state of RBQM adoption and what it will take for the industry to fully embrace risk-based approaches in clinical trials. Drawing on insights from ACRO’s annual industry survey, Jennife...

In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Adam Walker, a seasoned clinical data management and biometrics consultant. Together, they explore the delicate balance between innovation and the inherently risk-averse nature of the clinical research industry. With extensive experience working for companies of various sizes, Adam has had the opportunity to observe and lead the im...

Podcast Episode Summary In this episode of Clinical Data Talks , Sylvain Berthelot welcomes Chris Decker, President and CEO of Clinical Data Interchange Standards Consortium (CDISC) . Together, they explore the critical role that data standards play in modern clinical research and why greater standardisation is essential to improving how clinical trial data is collected, structured, and shared. Dr...

In 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 un...

In 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 poli...

Sylvain 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...

Join 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 highligh...

Sylvain 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 technolo...

In 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...

Applying 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 bein...

In 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 cul...

Join 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 clini...

In 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 ca...

The evolving role of data managers with Kelly Forester Sylvain 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, fro...

For 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 evolv...