mHealth App Engages Patients for Clinical Trials & Research Studies
Mobile health app simplifies data gathering for clinical trials and research studies. Data input by patients can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries.
NewPage took on the challenge of developing a Mobile Patient Engagement App that can be linked to electronic health data supporting clinical trials, pragmatic studies, observational studies and registries. The app would need to be configurable for different therapeutic areas and health outcomes, reducing software development hurdles for non-FDA users.
We determined that for this project we could utilize FDA MyStudies, an open-source platform for gathering real-world data for clinical trials and research studies. The data storage environment is secure and supports auditing necessary for compliance with HIPAA, FISMA, and 21 CFR Part 11. We quickly and easily customized the app, adding new capabilities with reusable components previously developed for another Digital Health solution. The data storage environment was partitioned to support multi-site trials or “distributed database” studies. Various modular components can be integrated with third-party systems of choice to create a tailored solution for the client. All study content as seen in the app can be authored and updated via the WCP web application rather than through new software development for each study or app. The app can be rebranded by researchers and developers.
NewPage developed the Mobile App (available for IOS and Android), which enables registration, enrollment, submission of responses, customizable push notifications, along with passcode and Touch ID access. The app allows participants to complete study activities even when offline. By leveraging FDA MyStudies and incorporating NewPage’s reusable enhancements, we were able to develop the new solution within 2-3 months, reducing development time by 75% when compared to the effort to develop a new app from scratch. This saved our clients both time and money.
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