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Cutting-edge approaches to trial and study design, technology, sourcing, data disclosure and medical communications.

Real World Evidence: Revolutionizing the Clinical Trials Environment - WHITEPAPER

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When FDA Commissioner M. Scott Gottlieb made his announcement in December 2018 of a new regulatory framework for Real-World Data (RWD) and Real-World Evidence (RWE), he clearly positioned the FDA in the side of those who have seen the huge opportunities in front of us. Today’s advanced technologies such as artificial intelligence platforms, commoditized data collection tools and large integrated healthcare IT infrastructures allow us to go one step further in harvesting and utilizing this data, in term allowing us to do everything from reducing costs in clinical trials to optimizing post-marketing study.

This whitepaper explores the nature of real-world evidence, various jurisdiction’s regulatory stance, review the impact of RWE on trial design and operations and discuss how to insure the data can be used in a regulatory context.

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ABOUT THE AUTHOR: Jean-Francois Denault, MBA has been working with innovators and entrepreneurs in life sciences as a professional consultant for over fifteen years. He has worked with over 50 different clients in life sciences located all over the world.

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