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State of Digital Clinical Trials Podcast
Clinical Data Innovation In A Non-EDC Centric World
Nov 1, 2023
Patrick Nadolny, Global Head of Clinical Data Management at Sanofi, discusses the future of EDC, new programs at Sanofi, and the need for a patient-driven trial model. They explore the evolving landscape of clinical data management, the impact and challenges of data management in clinical trials, and the importance of simplifying processes and partnering with technology providers for solutions. They also emphasize the need for continued experimentation and rethinking strategies in clinical data innovation.
38:05
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Quick takeaways
- The clinical trials industry is undergoing a transformation with the influx of new data sources, such as medical imaging and genomics, requiring a shift towards effective management and value extraction from diverse data sources.
- Regulatory changes and advancements in technology are driving the need for simplified trial designs, operational feasibility, and a focus on patient-driven trials that prioritize individual patient preferences and needs.
Deep dives
Transforming Data Management and Extracting Value from Data
The podcast explores the transformation of data management in the clinical trials industry. The speaker highlights the need for a shift from paper to electronic clinical data capture (EDC) and emphasizes that the transformation goes beyond EDC. The industry is experiencing an inflection point, with the influx of new types of data sources like medical imaging, genomics, and labs. The management of these diverse data sources and the extraction of value from them has become crucial. The speaker also mentions the changing landscape of clinical trials, with a move towards complex protocols, adaptive designs, and a focus on patient-centricity. Moreover, reducing the burden on sites and patients is seen as an important goal, aligning with the idea of patient-driven trials.
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