Paradigm Health announced the launch of a research collaboration with the 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.
Pharmaceutical companies Amgen and AstraZeneca are the first to join the collaboration. The new model has launched in an AstraZeneca-sponsored Phase 2 trial at sites including MD Anderson Cancer Center and Perelman School of Medicine at the University of Pennsylvania, as well as an Amgen-sponsored Phase 1b trial.
The Paradigm Health Study Conduct solution works by capturing data directly from electronic health records and other structured and unstructured sources, algorithmically evaluating FDA-defined data points and reporting criteria in real time, and transmitting only the critical signals and data needed for regulatory determinations to the trial sponsor and the FDA. Paradigm Health has engineered this infrastructure specifically for the collaboration, working closely with the FDA since early 2026 to define reporting and validation protocols, establish criteria for key regulatory events, and ensure FDA-Paradigm Health software and data interoperability. The data transferred through the real-time platform is traceable, auditable, and protects patient privacy, while minimizing the transfer of unnecessary datasets.
"This collaboration represents an important step toward expediting how clinical trial data is submitted to and reviewed by the FDA," said Kent Thoelke, Founder and CEO of Paradigm Health. "With Paradigm Health's platform, clinical trial data can be analyzed for key signals in near real time and shared with trial sponsors and the FDA in days, rather than months. This means that regulators, sponsors, and providers can have a continuous view of safety and efficacy. By modernizing the flow of information from sites to sponsors to regulators, we have an opportunity to accelerate the delivery of innovative therapies to patients across the country."
"The initiative leverages the best of U.S. technology and innovation to bolster clinical development in the United States," said Robert Nelsen, Co-Founder and Managing Director of ARCH Venture Partners and Paradigm Health Co-Founder and Board Chair. "This model can align the interests of policymakers, pharmaceutical and biotech companies, and American patients, and make U.S. clinical research faster and more cost-effective."