CVM’s Remote Access Pilot Program

Updated June 2026

FDA’s Center for Veterinary Medicine (CVM) runs the Remote Access Pilot Program through its Office of New Animal Drug Evaluation (ONADE). This pilot changes how study data reaches the agency. Instead of submitting copies of the data, sponsors give CVM reviewers read-only remote access to the study database in the EDC system where the data already lives.

How the CVM Remote Access Pilot Program works

During review, CVM reviewers log in to a read-only view of the sponsor’s EDC system. They see the source data and its audit trail together, in a database they can navigate, rather than a stack of exported spreadsheets and attachments. CVM has publicly described its standard copy-based review process as difficult to work with and has reported consistently positive feedback on the remote-access experience.

What it means for sponsors and CROs

Remote access removes the work of packaging study data into an eSubmitter-ready format, along with the file-size and upload limits that slow the standard process. Submissions are faster and less costly, and CVM reviews from the same system of record the study team used. Participating takes some setup documentation up front, which Prelude prepares and routes to the right people at CVM.

Prelude’s track record

Prelude has supported six study submissions through the program since 2020. CVM’s only public count of the program comes from a 2023 presentation that listed four submissions, and it has not been updated since. One of those six is public: VetDC’s TANOVEA, which received full FDA approval on July 15, 2021, the first conditionally approved dog drug to advance from conditional to full approval under FDA’s Minor Use and Minor Species (MUMS) program. Prelude’s EDC held the study data, and CVM had real-time access during the review.

The source material

The program and the TANOVEA approval are documented in public sources:

• CVM’s EDC Remote Access Pilot Program information (FDA)
• CVM’s QASR Hot Topics presentation, reporting the pilot’s findings and feedback (FDA)
• TANOVEA Freedom of Information Summary (FDA)
• How Prelude’s partner VetDC reached full approval (Prelude)

Planning a CVM submission? We can show you how remote access works for your protocol and what it takes to participate.