Clinical Data Talks

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.

Drawing on decades of experience in clinical technology and data solutions, Chris explains how CDISC standards have become a foundation for regulatory submissions and global data interoperability. He highlights what those standards enable to do, but also the work ahead of us to truly achieve the digital transformation the industry needs.

A key theme of the conversation is the growing importance of digitizing protocols and designing studies with standards in mind from the beginning. Chris shares how structured protocol models and machine-readable standards could transform study setup, reduce manual work, and enable greater automation across the clinical data lifecycle.

Tune in to discover how CDISC standards are shaping the future of clinical trials, why protocol digitization could be a turning point for the industry, and how better data foundations can unlock innovation in clinical research.

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 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, Sylvain and Anna discuss the rapid regulatory adaptations that allowed continuity of care, the growing demand for clinical trial participation among internally displaced persons, and the remarkable story of a young patient whose treatment continued thanks to cross-border collaboration.

Tune in to hear how clinical trials in Ukraine have not only survived but are resurging, and why patient trust, unity, and human-centered approaches are shaping the future of research in the region.

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 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 reluctant to rely on a U.S.-only model.

Scott explains how geopolitical factors such as trade tensions, FDA staffing challenges, and evolving diversity guidance impact trial planning, and why sponsors must think proactively about data representativeness across regions. The conversation also highlights the scientific – rather than political – benefits of conducting multi-regional trials, ensuring that new medicines reach the patients who need them most.

Tune in to discover how sponsors are mitigating risk, balancing timelines and costs, and navigating the new realities of trial globalization.

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, 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 cautious and bold when evaluating new tools, how to build trust with clients while innovating, and the importance of curiosity and adaptability in driving meaningful change.

Tune in to hear how CROs can move beyond “shiny new objects” and take a thoughtful, balanced approach to innovation in clinical trials.

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 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 also covers the promise and challenges of scaling eSource adoption: from interoperability standards like HL7 FHIR, to dealing with unstructured data using natural language processing. Mats emphasizes the role of AI as an assistant rather than a replacement, and why true progress requires aligning value across sponsors, hospitals, vendors, and regulators.

Tune in to learn more about eSource, the cultural shifts needed for sustainable adoption, and the guiding principles Mats applies – rooted in Nash equilibrium.

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 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 from legacy methods.

Sylvain and Joe discuss the importance of integration to reduce manual entry, how real-time data capture accelerates decision-making and improves quality, and why designing systems around the patient experience is critical to compliance and study success.

Tune in to hear how Spaulding Clinical built its operations from the ground up, the lessons learned along the way, and what going truly paper-free means for the future of clinical trials.

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 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 identify risks earlier, address root causes, and protect trial integrity.

Sylvain and Tanya discuss why regulators intentionally avoid a rigid definition of data surveillance, how cross-functional collaboration between statisticians, medics, and data managers is key, and why proactive strategies ultimately save both time and cost. 

Tune in to explore how data surveillance is reshaping the role of data managers, the culture of oversight, and the future of trial success.

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 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 evolving to support these efforts.

Cristina also reflects on cultural and organizational changes needed to integrate RWE into clinical development successfully, and how emerging technologies and cross-functional collaboration can drive this transformation.

Join us as we explore how real-world evidence is shifting from a buzzword to a critical component of evidence generation in modern clinical research.

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 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 evolving to support these efforts.

Cristina also reflects on cultural and organizational changes needed to integrate RWE into clinical development successfully, and how emerging technologies and cross-functional collaboration can drive this transformation.

Join us as we explore how real-world evidence is shifting from a buzzword to a critical component of evidence generation in modern clinical research.

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 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 confronting resistance and misconceptions. Brian offers practical insight into why RBQM is less about the tools and more about people, collaboration, and culture.

Tune in to discover what “good” risk management looks like and how to make it stick –across teams, trials, and organisations.