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 infrastructure. She shares how the landscape is shifting from a traditional focus on Phase 3 "rescue" trials toward early-phase research, driven by geopolitical changes and a growing need for diverse genetic data.

Sylvain and Claudia discuss the nuances of different markets, from Chile’s rapid regulatory timelines for medical devices to Brazil’s world-renowned Key Opinion Leaders. They also delve into the unique cultural bond between patients and physicians in the region, which results in remarkably high retention rates.

Tune in to our Season 3 finale to discover how strategic planning in Latin America can accelerate regulatory approval, provide a "soft landing" for future product launches, and ensure high-quality data that meets the rigorous standards of the FDA and EMA.

Unlocking Latin America’s clinical trial potential with Claudia Rodriguez

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 managers are no longer just handling EDC systems but are now coordinating a symphony of sources: from multi-omics and imaging to device data and patient-reported outcomes. She explains the friction that occurs when these heterogeneous sources "speak different languages," forcing data teams to spend their days reconciling time points and bridging semantic gaps to meet standardization requirements.

Sylvain and Kavita discuss why the industry is currently attempting to bolt 21st-century data onto 20th-century infrastructure, the necessity of viewing data as a strategic asset rather than a byproduct, and why oncology and precision medicine trials demand flexibility from technology first and foremost.

Tune in to learn why a holistic mindset shift in vendor selection and a learner’s attitude are essential for surviving—and thriving—in today’s complex clinical data environment.

The reality of data fragmentation in clinical trials with Kavita Gaadhe

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 the healthcare system as a cystic fibrosis patient, Ella shares the stark realities of trial participation: from the struggle for awareness in rural communities to the heavy physical and logistical burdens of complex procedures. She provides a poignant account of how rigid exclusion criteria can prevent the very patients who need new therapies most from contributing to essential data.

Sylvain and Ella discuss why the industry must move beyond traditional endpoints to capture what truly impacts a patient’s quality of life. They also dive into the necessity of optionality, explaining how flexible trial designs can improve enrolment, reduce attrition, and accelerate timelines.

Tune in to discover how true partnership between sponsors, regulators, and patient communities can transform trial design from a "one-size-fits-all" model into a meaningful, data-rich collaboration.

Clinical data from the patient's perspective with Ella Balasa

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, Jennifer shares a candid view of where progress is being made, and where challenges remain. While awareness of RBQM is high, true adoption is still inconsistent, with many organisations implementing elements in isolation rather than as a fully integrated strategy. She explains how this partial adoption limits the overall impact on trial quality and efficiency.

Sylvain and Jennifer discuss the key barriers holding the industry back, from persistent reliance on traditional practices like 100% SDV to misconceptions about regulatory expectations. They also highlight the growing role of regulators in encouraging risk-based approaches and why clearer communication and industry confidence are critical to driving change.

Tune in to explore how RBQM is evolving, what the latest data tells us about adoption trends, and why shifting mindset – not just technology – is essential to unlocking its full potential.

The adoption of centralized monitoring by CROs with Jennifer Stewart

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 implementation of innovation. In this episode, he shares his observations and discusses the tension between innovation and established processes, highlighting how legacy workflows can sometimes limit progress. He and Sylvain reflect on the challenge of introducing new technologies into environments where teams are incentivized to avoid risk, and where change can feel disruptive rather than enabling.

Adam makes an important point about the importance of mindset and culture. He emphasizes that innovation is not just about technology itself, but about creating an environment where teams feel confident to challenge the status quo, rethink processes, and adopt new ways of working.

Tune in to explore how the clinical industry can strike the right balance between stability and innovation, why risk aversion can both protect and hinder progress, and what it will take to unlock meaningful transformation in clinical trials.

Innovation in a risk-averse industry with Adam Walker

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.

The role of standardisation in clinical trials with Chris Decker

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.

Beyond the data: Human stories from clinical trials in Ukraine

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.

The impact of geopolitics in clinical trial location with Scott Schliebner

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.

Striking the right balance between risk and innovation with Marek Wasiluk

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.

Leveraging eSource in clinical data collection with Mats Sundgren

Clinical Data Talks is your go-to podcast for an in-depth look at the evolving world of clinical data capture, management and analysis.

Join industry experts and clinical data enthusiasts as we explore the challenges, breakthroughs and innovations shaping the industry. Through fresh perspectives, real-world experiences and forward-thinking discussions, we keep you informed on the latest trends driving the future of clinical trials.

Whether you’re a data manager, researcher or passionate about the industry, Clinical Data Talks is your trusted source for insights into the world of clinical data.

Sylvain Berthelot

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