In this article with HIT Consultant, Tiffany Siu Woodworth, Director of Analytics Solutions at Panalgo, discusses RWE within the regulatory landscape. She notes how in recent years, RWE has played an increasingly important role in life sciences companies and is now gaining acceptance by regulatory agencies. But simple RWE isn’t enough for regulatory submissions – it has to be trustworthy in order to be effective. To that end, Woodworth outlines her “three Rs” of generating trustworthy RWE that can be used for regulatory submission: repeatability, reproducibility, and replicability.
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