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PODCAST

Clinical Data Talks

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

science life sciences

All Episodes

30:35

Striking the right balance between risk and...

Clinical Data Talks ·

2025/10/29

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

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29:09

Leveraging eSource in clinical data collection with...

Clinical Data Talks ·

2025/10/15

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

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26:54

Going paper-free in early phase trials with Joe Erato

Clinical Data Talks ·

2025/10/01

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

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29:21

Making data surveillance a reality with Tanya Du Plessis

Clinical Data Talks ·

2025/09/17

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

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26:44

Applying real world evidence to clinical trials with...

Clinical Data Talks ·

2025/08/04

Applying real world evidence to clinical trials with Cristina ChangIn 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

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26:44

Applying real world evidence to clinical trials with...

Clinical Data Talks ·

2025/06/04

Applying real world evidence to clinical trials with Cristina ChangIn 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

en

22:18

Realising the true benefits of risk management with...

Clinical Data Talks ·

2025/05/21

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

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27:49

A new way of defining clinical endpoints with...

Clinical Data Talks ·

2025/05/07

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

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26:37

The future of technology and AI in clinical trials...

Clinical Data Talks ·

2025/04/23

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

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24:12

The evolving role of data managers with Kelly Forester

Clinical Data Talks ·

2025/04/09

The evolving role of data managers with Kelly ForesterSylvain 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

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31:01

The challenges and promises of the clinical data...

Clinical Data Talks ·

2025/03/26

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,

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11 results

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