ClinicalTrials.gov Registration & Results Reporting

The contract requires the registration of clinical investigations involving digital health technologies on ClinicalTrials.gov and the timely submission of trial results in full compliance with the Food and Drug Administration Amendments Act reporting mandates. This subcontract pertains to ensuring that all applicable studies meet federal transparency and disclosure standards, with responsibilities encompassing accurate data entry, adherence to timeline requirements, and alignment with regulatory guidelines for clinical trial reporting. The opportunity is issued by the Food and Drug Administration under the Department of Health and Human Services, with a North American Industry Classification System code of 621399 for other miscellaneous health practitioners. The solicitation was posted on July 20, 2026, and responses are due by August 20, 2026. There is no specified place of performance or point of contact, and no set-aside type is indicated. The contract applies broadly to entities capable of managing the technical and regulatory demands of registering and reporting on clinical trials involving digital health technologies, with the primary focus on fulfilling statutory obligations to enhance public access to clinical trial information.