In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Khaudeja Bano, an industry leader with over 25 years of experience across top pharmaceutical companies and deep expertise in diagnostics, therapeutics, and combination products. Together, they unpack compliance and safety management for combination products and examine how rapid drug-device innovation is moving healthcare directly into patients' hands.

With a distinguished background that includes serving on the working group that helped establish 21 CFR Part 4 regulations, Khaudeja shares how the rise of GLP-1 auto-injectors and drug delivery systems is redefining safety data collection. She explains why pharmaceutical sponsors must take holistic ownership of safety, efficacy, and risk management across the entire product – from evaluating human factors and needle protection to feeding real-world usability data back into next-generation device design.

Sylvain and Khaudeja discuss the nuances of global regulatory frameworks across the US FDA, EMA, and PMDA, why the controlled environment of clinical trials offers an ideal setting to listen to the patient voice, and how bringing technology partners directly to the regulatory table creates smoother compliance workflows.

Tune in to explore how combination products are reshaping safety surveillance, cross-industry collaboration, and the future of patient-centered healthcare.

Mastering compliance for combination products with Dr. Khaudeja Bano

Sylvain Berthelot welcomes Craig Mooney to the podcast, Founder and Principal Consultant at IRT Advisors Group. Together, they unpack the trade-offs between standalone point solutions and unified eClinical platforms, exploring how sponsor growth shapes technology choices in clinical trials.

With over three decades of clinical trial experience, Craig shares insights from his article Choose Your Hard, explaining why there is no single "right" answer when selecting trial software.

He and Sylvain discuss the context that may lead CROs and sponsors to choose specialized point solutions instead of integrated platforms. They also address the hidden operational costs of data reconciliation, why discrepancies like visit dates versus transaction dates are often misunderstood, and how unified platform architectures can eliminate artificial data friction.

Tune in to explore how organizational scale, system design, and decision-making structures impact the future of clinical trial technology.

Growth and the impact on clinical technology with Craig Mooney

In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Vivienne van de Walle, founder of PT&R, an independent clinical site she has successfully led for nearly 30 years. Together, they explore what it takes to make clinical sites truly want to participate in clinical trials and how site-level challenges impact the broader research ecosystem.

Drawing on decades of on-the-ground experience, Vivienne highlights the growing operational burden placed on sites and patients due to technology overload and complex study protocols. From the alarming rate of "once-and-done" investigators dropping out after their first trial to Clinical Research Coordinators drowning in standalone systems, she sheds light on how software complexity drives talent out of the industry while taking time away from direct patient care.

Sylvain and Vivienne discuss why true patient centricity requires reducing trial burden rather than just collecting more data, how consulting sites early in study design prevents costly protocol deviations, and why rushing trial setup timelines creates severe downstream friction for site operations.

Tune in to explore how sponsors can foster better collaboration with sites, simplify digital workflows, and create a more sustainable environment for clinicians, site staff, and patients alike.

How to make sites want to take part in clinical trials with Vivienne van de Walle

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

Sylvain Berthelot (@sylvain_crscube) · Zencastr

Sylvain Berthelot (@sylvain_crscube)

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.