FDA MyStudies – Streamline clinical trials and data collection with real time, patient-reported outcomes.

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PLATFORM

Web & Mobile

Developing an end-to-end solution in the form of an application suite to launch and run research studies was a priority for the FDA. The FDA’s MyStudies app gives research study participants a convenient way to provide clinical trial research experience in real-time via their iOS or Android device. Users can also easily receive important notifications and reminders in relation to survey participation, all in one easy-to-use application that is both HIPAA and FISMA compliant.

How come

How
We
Helped

The biggest challenge that the FDA had was delivering on the ACA mandate to  “build data capacity for comparative clinical effectiveness research.”

The FDA was to establish a program to evaluate the potential use of real-world evidence to support a new indication for an approved drug as well as post-approval study requirements.

FDA’s MyStudies delivers:

  • Mobile app
  • Standard frameworks:   ResearchKit (iOS) &  ResearchStack (Android)
  • Gateway capability
  • Web-based configuration portal
  • SurveyMonkey for ResearchKit
  • Secure storage environment
  • FISMA-compliant
  • Partitioned for distributed research
  • Responses are available in broadly compatible formats (e.g., SAS, Excel)
  • Reusable infrastructure
  • Enrollment and consent
How come

How
We
Delivered

BTC built the FDA MyStudies open source platform designed for researchers and developers.

The benefits are abundant:

  • Ongoing, real-time data entry
  • Configurable questionnaires and secure data management
  • More frequent “touchpoints” for real world data collection
  • Automatic capture of contextual real world metadata
  • Enhanced convenience may aid recruitment, engagement and retention

 

How come

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All the Advantages That Digital Delivers.