Paradigm Health Announces Collaboration with the FDA to Transform Regulatory Review of Clinical Trial Data

The initiative will be implemented in two trials, using Paradigm Health's integrated technology platform to accelerate FDA review

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.

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."

Building the Future of U.S. Clinical Trials

The need for modernization in clinical development is urgent, as innovation in U.S. clinical trial infrastructure has not kept pace with the volume of therapeutic candidates under investigation. Trials are long, complex, and expensive. This collaborative model, if deployed successfully and at scale, can help bring new medicines to American patients faster. Furthermore, efficient, less expensive trials make the United States a more compelling and competitive place for innovative companies to conduct research.

This collaboration directly supports the FDA's strategic goal of moving toward a real-time, continuous regulatory environment, and underscores Paradigm Health's commitment to modernizing drug development infrastructure and expanding access to cutting-edge clinical research regardless of where patients live.

About Paradigm Health

Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit https://www.paradigmhealth.ai.

SOURCE Paradigm Health, Inc.