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

Project Title CDER SBIA Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies
Date
Thursday, May 9, 2019
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 will demonstrate the capabilities of the system as well as 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.

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

More details about this event are available on FDA's website .

Host

U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA)

Location

Adobe Connect Webcast
Note: Link will be e-mailed after registration. Room opens 15 minutes prior to webinar.

Register for the Webinar here.

Presenters

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 

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