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

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

Register Now  May 9, 2019 | 10:00 a.m. to 3 p.m. Eastern | Thursday This webinar is FREE. Agenda 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 healthcare space Foreign regulators TOPICS COVERED Hear directly from FDA subject matter experts on the use of digital tools such as the FDA MyStudies platform to gather real-world data for research and help inform regulatory decision-making. Understand the capabilities of the mobile apps built on iOS ResearchKit and Android ResearchStack frameworks, respectively. Learn how the code base of these apps is designed to make them ‘framework apps’ and can be replicated for any number of studies, with minimal coding effort, to set up new apps for new studies. Observe in real-time how study content can be created, published, and managed using the web-based Configuration Portal. See how those changes are reflected dynamically in the mobile apps and the Response Server. Take a deep dive into the capabilities and architecture of the Response Server to understand how responses are processed and stored. Learn about the many options provided for retrieving and analyzing these data, including linking responses to patient records. Register Now