Jonathan Hirsch, Chief Strategy and Growth Officer at Paradigm Health, posted on LinkedIn:
“Today, the FDA announced the launch of a landmark research collaboration with Paradigm Health to transform the regulatory review of clinical trial data.
This initiative focuses on advancing our technology-enabled model to accelerate clinical trial execution and regulatory review. Paradigm Health’s Study Conduct platform enables real-time regulatory review by automating data collection, analysis, and streamlining the reporting of key key signals to trial sponsors and the FDA. We have implemented the platform in a Phase 2 trial and a Phase 1b trial with two major pharmaceutical companies.
The goal is to establish a scalable model to reduce monitoring burden, data entry, and trial costs, ultimately accelerating the regulatory review process and making U.S. clinical trials more efficient. As our CEO Kent Thoelke said, our platform allows data to be analyzed and shared in ‘days, rather than months,’ giving regulators and sponsors a continuous view of safety and efficacy.
This is a critical step toward modernizing drug development infrastructure and expanding access to cutting-edge clinical research for more patients.
Learn more about how we are working to bring potentially life-saving therapies to patients faster.”
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