David Martin from FDA’s Office of Medical Policy provides an overview of the FDA MyStudies platform, real world evidence and real world data. This platform can be used to configure and create branded apps in traditional clinical trials as well as real world evidence studies and registries.
The webinar demonstrates the capabilities of the system, its associated web-based configuration portal, and data storage environment. Developers will receive an orientation to the GitHub repository and will learn helpful tips for setting up and configuring the system for study managers and participants.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
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