For sponsors and CROs exploring new sites for clinical research, Veterans Affairs (VA) hospitals are often overlooked—but they shouldn’t be. VA sites offer access to well-established infrastructure, highly experienced investigators, and one of the largest integrated health systems in the U.S. However, engaging with the VA comes with its own set of requirements, starting with the need for a CRADA.
A Cooperative Research and Development Agreement (CRADA) is the contractual framework that allows private companies to conduct research in partnership with federal institutions, including VA medical centers. When a sponsor wishes to conduct a clinical trial at a VA site, a CRADA must be in place between the sponsor (or its CRO) and the VA. This agreement outlines responsibilities, use of funds, publication rights, IP considerations, and other federal-specific obligations.
While the CRADA process can appear more complex than a typical CTA (Clinical Trial Agreement), the benefits of working with VA sites often outweigh the perceived challenges. One potential hurdle is that negotiations are handled by the VA’s legal team—specifically, the Specialty Team Advising Research (STAR). This centralized legal review ensures federal compliance and can lead to longer turnaround times if not managed proactively. Sponsors should also be aware that there is less flexibility to negotiate terms related to liability, indemnification, and insurance, due to federal protections and statutory limitations.
However, there are key strategic advantages to working with VA research sites. Once a CRADA has been reviewed and approved by a STAR attorney, that same template can often be leveraged at multiple VA locations without requiring full renegotiation. For multi-site studies within the VA system, this can significantly reduce administrative timelines and support faster study start-up. Additionally, VA sites often have built-in patient referral systems, electronic health records (EHR) access, and investigators with deep experience in working under federal protocols. This enables sponsors to more efficiently access a broader and often underrepresented patient population through a unified research infrastructure.
In addition to contractual differences, budget negotiations at VA sites follow federal rules and internal VA procedures, which can differ from standard industry expectations. While fair market value remains important, sponsors should understand that VA research offices often require detailed justifications for costs and may involve additional layers of review before budgets are approved. Indirect cost rates may be governed by VA policy or affiliated non-profit research entities, limiting flexibility in certain line items. However, once a CRADA budget has been approved at one site, it can often be replicated or used as a template at additional VA sites, streamlining multi-site budget alignment. Having a clear strategy and experienced partner in navigating these requirements can make a significant difference in start-up timelines.
If you’re navigating the complexities of CRADAs or looking to better align expectations when working with VA research sites, our team is here to help. Contact us to learn how we support our partners through every step of the process at [email protected] or visit our website at www.iceglobalconsulting.com.