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PARADIGM HEALTH SUBMITS RESPONSE TO FDA'S REAL-TIME CLINICAL TRIALS INITIATIVE RFI, INFORMED BY BIOPHARMA SPONSORS AND PROVIDERS
[June 30, 2026]

PARADIGM HEALTH SUBMITS RESPONSE TO FDA'S REAL-TIME CLINICAL TRIALS INITIATIVE RFI, INFORMED BY BIOPHARMA SPONSORS AND PROVIDERS


COLUMBUS, Ohio, June 30, 2026 /PRNewswire/ -- Paradigm Health, the sole technology provider operationalizing the U.S. Food and Drug Administration's (FDA) Real-Time Clinical Trials (RTCT) proof-of-concept studies, has formally submitted its response to the FDA's Request for Information (RFI) regarding the Real-Time Clinical Trial Initiative.

The submission draws from Paradigm Health's deployment of its AI-enabled clinical trial infrastructure across a diverse U.S. network of community, rural, and academic health systems, as well as numerous recent exploratory discussions with pharmaceutical and biotech sponsors interested in the pilot phase of the RTCT initiative. While individual pilot discussions remain confidential, aggregated insights from these conversations demonstrate an industry-wide eagerness to pursue new models to make clinical trials more efficient, cost-effective, and accessible.

  • Sponsor Interest: Paradigm Health has engaged in discussions with more than 20 large pharmaceutical companies and more than 10 small- to mid-sized biotechs on RTCT pilots and application development
  • Clinical Trial Reach: The conversations explored dozens of trials across multiple therapeutic areas, including cardiometabolic, cardiovscular, immunology, oncology, ophthalmology, and rare disease therapeutics
  • Potential Trial Sites: Already, more than 25 of Paradigm Health's provider organization partners–including community, integrated, and academic medical centers–have expressed interest in participating in these pilot trials. Each of these organizations has multiple sites within their systems and represent varied geographies from across the United States
  • Projected System Impact: In addition to the potential cost and time savings that are dependent on trials selected for the pilot, this initiative has the opportunity to meaningfully strengthen communication between regulators and trial sponsors, given the necessary dialogue for trial setup, agreement on endpoints and signals, as well as regular trial touch-points

"The FDA's vision for a Real-Time Clinical Trial infrastructure is exactly the kind of reform the life sciences ecosystem needs to accelerate life-saving therapies to U.S. patients. Our RFI submission reflects hard operational and technological realities gathered from our health system and sponsor partners," said Kent Thoelke, Founder and CEO of Paradigm Health. "Paradigm Health's model shows that when you embed intelligent, real-time data capture directly into a clinician's existing electronic health records, you can accelerate data collection and analysis, improve data quality and completeness, and reduce data entry burden for doctors. Paradigm Health is fully committed to supporting the FDA and our industry peers in executing this vital pilot phase."

The RTCT initiative, along with Health and Human Services' recently launched Operation Trialblazer, which aims to maintain U.S. leadership in early clinical research and development, demonstrate important momentum toward modernizing the domestic clinical research ecosystem.


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 paradigmhealth.ai.

In April 2026, Paradigm Health announced a landmark research collaboration with the FDA focused on advancing a new model to accelerate clinical trial execution and regulatory review. The model uses Paradigm Health's technology-enabled Study Conduct platform to allow 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.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/paradigm-health-submits-response-to-fdas-real-time-clinical-trials-initiative-rfi-informed-by-biopharma-sponsors-and-providers-302814900.html

SOURCE Paradigm Health, Inc.


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