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.
The role of standardisation in clinical trials with Chris Decker
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.
26 Nov 2025
Beyond the data: Human stories from clinical trials in Ukraine
Anna Titkova recounts her experiences overseeing clinical trials in Ukraine before and during the conflict, highlighting the resilience and adaptability of researchers and patients, in an interview with Sylvain Berthelot.
12 Nov 2025
The impact of geopolitics in clinical trial location with Scott Schliebner
Scott Schliebner, Global Head of Drug Development Consulting at Novotech, examines the impact of global politics and market dynamics on clinical trial locations, in an interview with Sylvain Berthelot.
29 Oct 2025
Striking the right balance between risk and innovation with Marek Wasiluk
CEO Marek Wasiluk discusses with Sylvain Berthelot how clinical research organizations balance innovation with risk management to improve trial quality and deliver value to sponsors and patients in this interview episode.
15 Oct 2025
Leveraging eSource in clinical data collection with Mats Sundgren
Mats Sundgren, Senior Advisor, discusses eSource implementation in clinical research with Sylvain Berthelot, revealing its transformative impact on efficiency and data quality by reducing manual data entry, in this interview.
1 Oct 2025
Going paper-free in early phase trials with Joe Erato
Joe Erato, Chief Operations Officer, details Spaulding Clinical's journey to paper-free early phase trials in an interview with Sylvain Berthelot, highlighting the challenges and benefits of adopting fully electronic systems.
17 Sept 2025
Making data surveillance a reality with Tanya Du Plessis
Tanya Du Plessis, Chief Data Strategist, defines data surveillance and its practical application in clinical trials, emphasizing proactive risk identification and cross-functional collaboration in this interview with Sylvain Berthelot.
4 Aug 2025
Applying real world evidence to clinical trials with Cristina Chang test 1
Cristina Chang, Chief Medical Officer at HiRO, explores the increasing significance of real-world evidence in clinical trials and its effects on patient outcomes, regulatory submissions, and post-marketing strategies in an interview with Sylvain Berthelot.
4 Jun 2025
Applying real world evidence to clinical trials with Cristina Chang
Cristina Chang, Chief Medical Officer at HiRO, examines the increasing significance of real-world evidence in clinical trials, focusing on enhancing patient outcomes and regulatory submissions in an interview with Sylvain Berthelot.
21 May 2025
Realising the true benefits of risk management with Brian Barnes
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.
7 May 2025
A new way of defining clinical endpoints with Sebastien Coppe
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 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. Sébastien emphasizes the need to rethink how we measure success in trials, through real-world impact and patient relevance.
Tune in to discover how new statistical approaches are enabling a more meaningful way to define what good looks like in clinical research.
23 Apr 2025
The future of technology and AI in clinical trials with Joe Dustin
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 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, and how standardization efforts like the USDM (Unified Study Definitions Model) are paving the way for faster and more efficient studies.
This conversation is packed with valuable perspectives on where clinical technology is heading.
Clinical Data Talks is a podcast brought to you by CRScube, a leader in eClinical technology solutions.
9 Apr 2025
The evolving role of data managers with Kelly Forester
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, 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 career development, mentorship, and the growing importance of soft skills and cross-functional collaboration.
Tune in to discover how data managers are not just keeping pace with change but driving it.
Clinical Data Talks is a podcast brought to you by CRScube, a leader in eClinical technology solutions.
26 Mar 2025
The challenges and promises of the clinical data lifecycle with Doug Bain
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 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 persistent issues like data fragmentation and interoperability while embracing innovations that enhance data integrity and usability.
Tune in to learn more about the clinical data life cycle and what’s shaping its future.
Clinical Data Talks is a podcast brought to you by CRScube, a leader in eClinical technology solutions.
Who has been a guest on Clinical Data Talks
Names identified in recent episode analyses. Showing up to five guests.
Anna Titkova
Scott Schliebner
Marek Wasiluk
Mats Sundgren
Joe Erato
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