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

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

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

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

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

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

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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.

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.

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.

      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.

      Innovative Technologies

      EXPIRED: Advancing pathogen reduction technologies for whole blood

      Data Solutions

      EXPIRED: Real World Data Research in Hematologic Malignancies

      Data Solutions

      EXPIRED: Research to Improve the Health and Safety of Women

        Frequently Asked Questions

        Got 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 Workshop on Patient-Generated Health Data in Medical Device Development

          Triangle CERSI research partner, Digital Medicine Society (DiMe), co-hosts a workshop with FDA on June 26-27, 2024 on how patient-generated data, including digitally derived and sensor-generated measures, can promote innovation and inclusivity in medical device development. There is no cost to register but registration is required.