Data Management and Coding Book Development

The contract involves developing and maintaining a secure data management system tailored for de-identified clinical data. Key deliverables include a finalized coding book, rigorous data validation processes, and adherence to an FDA-approved data management plan, ensuring compliance and data integrity throughout the project. This effort supports clinical research data handling with a focus on security and regulatory standards. Scheduled as a subcontract under the NAICS code 518210, the work will be performed in Silver Spring and is overseen by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services. The solicitation was posted on June 8, 2026, with a response deadline of July 6, 2026, emphasizing a timely and collaborative approach to secure and efficient management of clinical data assets for regulatory and research purposes.