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CDER SBIA Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies

    Event Information
    Date
    Time
    Time
    10:00am - 3:00pm EST
    Event Type
    Webinar
    Description

    The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries.

    This event demonstrated the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers received an orientation to the GitHub repository and learned helpful tips for setting up and configuring the system for study managers and participants.

    Intended Audience:​

    • Professionals involved in Clinical Research, Post Market Studies, Regulatory Affairs, Medical Affairs, Real World Evidence, Health Economics and Outcomes Research, and Population Health Management
    • Application developers and Secure Data Storage and Analytics Solutions developers working in the health care space
    • Foreign regulators

    Date: May 9, 2019
    Time: 10:00 AM - 3:00 PM EST
    Location: Webinar

    Event Materials

    Webinar Recordings & Materials: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019

    The following sessions of the webinar were recorded. Please visit the link above for more details.

    • Session One: Introduction to FDA MyStudies Mobile App System
    • Session Two: A Demonstration of the FDA MyStudies Mobile App System: Patient and Researcher Experiences
    • Questions and Answers
    • Session Three: Mobile Application and WCP: Usability and Technical Overview
    • Session Four: Response Server Technical Overview
    • Session Five: Deploying the MyStudies System in a Compliant Manner
    • Questions and Answers and Closing Remarks
       
    Presenter(s)

    David Martin, MD, MPH
    Associate Director for Real World Evidence Analytics
    Office of Medical Policy
    Center for Drug Evaluation and Research (CDER)
    FDA

    Shyam Deval, MS, MBA
    President & Chief Customer Officer
    Boston Technology Corporation

    Ranjani Rao, MS
    Chief Technology Officer
    Boston Technology Corporation

    Adam Rauch
    Vice President of Product Strategy
    LabKey Software

    Stuart MacDonald
    Director of Systems Engineering
    LabKey Software

    Jeffrey Brown, PhD
    Associate Professor
    Department of Population Medicine
    Harvard Medical School & Harvard Pilgrim Health Care Institute

    Zachary Wyner, MPH
    Senior Health Informatics Analyst
    Department of Population Medicine
    Harvard Medical School & Harvard Pilgrim Health Care Institute