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To learn more about Triangle CERSI, join our mailing list for future communications.

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To learn more about Triangle CERSI, join our mailing list for future communications.

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To learn more about Triangle CERSI, join our mailing list for future communications.

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To learn more about Triangle CERSI, join our mailing list for future communications.

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To learn more about Triangle CERSI, join our mailing list for future communications.

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Triangle CERSI

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Who We Are

Triangle CERSI was established in 2023 as an FDA Center of Excellence in Regulatory Science and Innovation. We accelerate access to emerging scientific approaches essential for the FDA to remain at the forefront of regulatory decision making.

About Triangle CERSI

Challenge/Solution

Balancing the need to efficiently approve new products and tools while ensuring safety and efficacy requires robust scientific collaboration. The FDA established the CERSI Program to enhance its capabilities.

View our Research

Smarter Regulating

We bring value to regulatory science through unique expertise in complex emerging technologies and analytic approaches as well as our commitment to education, workforce training, industry partnerships, and community engagement.

In the News
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    The University of North Carolina at Chapel Hill
    Duke University
    North Carolina Central University
    North Carolina State University

    Technological Innovations to Evolve Regulatory Decision Making

    New technologies are constantly emerging onto the scene, aided by artificial intelligence and computational innovations. From precision health to regenerative medicine; from novel foods & ingredients to the microbiome; from manufacturing to predictive tools, the Triangle CERSI conducts research to help the FDA keep pace.

    Project Example

    Solutions to Harness Information, Augment Data Quality and Modernize Clinical Trials

    Today’s clinical trials are significantly more complex than before, necessitating new approaches for how we collect, analyze, and learn from data. The Triangle CERSI works to deliver novel statistical methods and tools to enhance trial design and interpretation while harnessing improved efficiencies.

    Project Example

    Engaging with Patients, Consumers & Workforce to Understand Preferences, Perspectives and Differences

    Patients and consumers are not passive recipients but active stakeholders in their own health and wellbeing. Of vital importance to Triangle CERSI is the inclusion and understanding of various perspectives, preferences and differences when evaluating safety and effectiveness of regulated products.

    Project Example

    Initiatives to Promote Health, Wellness & Resiliency

    When natural disasters strike or public heath crises emerge, it is essential to have the tools, knowledge, and resources to effectively respond and recover. Triangle CERSI tackles complex challenges, like America’s opioid crisis as an example, using multifaceted and creative approaches to address prevention, treatment and building individual and community resilience.

    Project Example

      Explore Requests for Project Ideas

      This section includes opportunities for researchers from CERSI organizations to respond to FDA-initiated requests for short proposals describing ideas for projects they may wish to fund.

      AI-enabled medical devices

      EXPIRED 7/14/25: CDRH requests proposals to develop tools to support post-market performance monito…

      Real World Data, Real World Evidence

      EXPIRED 6/9/25: FDA CDER Office of Medical Policy 3 Topics re Real World Data

      Innovative Technologies

      EXPIRED 1/31/25: Development & Evaluation of Novel Trial Endpoints Using Digital Health Technologies

        Frequently Asked Questions

        Have questions? Check out our FAQ section for quick answers to common questions.

        The timeline for each stage of the research lifecycle varies. Generally speaking, the timeline for responding to a request for short proposal ranges from 3-6 weeks. The timeline from submitting a short proposal to being invited to submit a full proposal ranges from 4-8 weeks. The timeline from submitting a full proposal to project launch ranges from 2-10 months. The timeline for conducting a study ranges from 1-2 years, with extensions considered and granted on a case-by-case basis.

        The funding amount for each project is determined by the FDA office requesting the project idea. Though it varies, the average amount is around $350,000 for a 2 year project, including direct and indirect costs.

        The CERSI program was established to advance regulatory science individually and synergistically through collaborative interactions with FDA. Through the CERSI program, researchers in our consortium are paired with FDA subject matter experts (SME) on a particular topic of interest. Together, they collaborate on projects by working on study design, helping to interpret results and participating in outcomes of interest toward informing regulatory decision making.

          FDA Updates List of FDA-authorized AI-enabled medical devices

          On July 10, 2025, FDA published updated list of AI-enabled medical devices authorized for use in clinical trials, including those using Augmented Reality and Virtual Reality (AR/VR), and Medical Devices that Incorporate Sensor-based Digital Health Technology (sDHTs). 

          Learn More