Paradigm Health announced a new research collaboration with the Food and Drug Administration (FDA) aimed at speeding clinical trial execution and regulatory review through real-time data review.
The model uses Paradigm Health’s technology-enabled Study Conduct platform to automate data collection and analysis while streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA. Paradigm said the approach is designed to reduce monitoring burden, data entry, and trial costs, while improving the efficiency of U.S. clinical trials and helping bring treatments to patients faster.
The model is already being used in two studies: an AstraZeneca-sponsored Phase 2 trial at sites including MD Anderson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania, and an Amgen-sponsored Phase 1b trial. Amgen and AstraZeneca are the first pharmaceutical companies to join the collaboration.
