Regulatory Compliance and Clinical Data Management Consulting

The contract seeks advisory services to ensure a clinical trial documentation portal complies with federal regulatory standards, with a strong emphasis on FDA 21 CFR Part 11 requirements, including electronic records and signatures, comprehensive audit trails, and robust data integrity controls. The scope centers on guiding the development and implementation of technical and procedural safeguards that validate the authenticity, accuracy, and traceability of clinical data submitted for regulatory review. The contractor will provide expert consultation to align system design and operational workflows with current regulatory expectations, reducing risk of noncompliance and ensuring readiness for agency inspections. This subcontract is solicited by the National Institutes of Health under the Department of Health and Human Services, with performance expected to occur in a location with ZIP code 20852. The North American Industry Classification System code 541690 indicates it falls under other scientific and technical consulting services. The opportunity was posted on May 13, 2026, with a response deadline of May 23, 2026, and is categorized as a subcontract without a specific set-aside designation. Interested parties must submit proposals by the stated deadline to be considered for engagement in supporting critical clinical data management infrastructure.