Paradigm Health and FDA Begin Collaboration on Real Time Clinical Trial Review

Paradigm Health has launched a research collaboration with the U.S. Food and Drug Administration focused on developing a model for faster clinical trial execution and regulatory review, announced in a press release. The model uses Paradigm Health's Study Conduct platform to enable the FDA to review data in real time by automating collection, analysis, and reporting of key safety and efficacy signals.

The collaboration is already active in a Phase 2 trial sponsored by AstraZeneca and a Phase 1b trial sponsored by Amgen. Sites participating include MD Anderson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania. The system captures data directly from electronic health records and other sources, evaluates FDA-defined criteria, and transmits only critical information to the FDA and sponsors.

Paradigm Health has worked with the FDA since early 2026 to establish protocols for reporting, validation, and interoperability between systems. The platform is designed to reduce data entry and monitoring requirements while maintaining data traceability and patient privacy. The goal is to create a scalable model that lowers trial costs and shortens the time needed for regulatory review.