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Paradigm Health Announces Collaboration with the FDA to Transform Regulatory Review of Clinical Trial Data [Yahoo! Finance]
Last amgen inc. earnings: 4/30 04:01 pm
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US:NASDAQ Investor Relations: investors.amgen.com
WASHINGTON and COLUMBUS, Ohio April 28, 2026 /PRNewswire/ -- Today, Paradigm Health announced the launch of a landmark research collaboration with the U.S. Food & Drug Administration (FDA) focused on advancing a new model to accelerate clinical trial execution and regulatory review. The new model, already operational in a Phase 2 and Phase 1b trial, uses Paradigm Health's technology-enabled Study Conduct platform to enable real-time review by the FDA, by automating data collection and analysis, and streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA. The goal is to establish a scalable model that reduces monitoring burden, data entry, and trial costs—speeding regulatory review, improving U.S. clinical trial efficiency, and accelerating cures to patients. Paradigm Logo (PRNewsfoto/Paradigm Health, Inc.) Pharmaceutical companies Amgen and AstraZeneca are the first to join the collaboration. The new model has launched in an AstraZeneca-sponsor
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- FDA Announces Major Steps to Implement Real-Time Clinical Trials [Yahoo! Finance][Yahoo! Finance]
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