Research Compliance and Regulatory Support

The contract seeks a small business to provide comprehensive consulting services aimed at ensuring full compliance with Good Clinical Practice guidelines, FDA Investigational New Drug requirements, protections for human subjects, and Veterans Affairs Institutional Review Board regulations for clinical trial operations. The work will focus on supporting the Department of Veterans Affairs in maintaining regulatory integrity across all phases of clinical research conducted at the place of performance in Providence, Rhode Island, with a specific emphasis on adherence to federal and institutional standards governing human research and drug development. Services will involve advising on protocol design, documentation, monitoring, reporting, and training to align with evolving regulatory expectations and ensure ethical and lawful research conduct. The opportunity is structured as a subcontract under a Small Business Set Aside, classified under NAICS code 541620 for management, scientific, and technical consulting services. The solicitation was posted on July 30, 2026, with responses due by August 13, 2026, and is managed by the 241-NETWORK Contract Office 01 within the Department of Veterans Affairs. While no point of contact is listed, the place of performance is fixed in Providence, and the contract requires expertise in navigating complex regulatory frameworks across multiple federal and VA-specific oversight bodies. Contractors must demonstrate proven ability to support clinical research integrity while operating within the constraints of a small business designation and federal procurement guidelines.