Sentinel: Sentinel System Data Platform BPA

The Food and Drug Administration is establishing a single, multiple-award, tiered contract for the Sentinel System 3.0 Data Hub to ensure program continuity. This initiative is designed to fulfill FDAAA mandates by creating an Active Postmarket Risk Identification and Analysis system capable of accessing, linking, and analyzing disparate data sources. The Data Hub will provide the necessary infrastructure and analytic support services to evaluate safety data for all CDER medical products using real-world data. This forecast opportunity falls under NAICS code 541690 and utilizes a diverse range of funding sources, including BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds. The project aims to develop validated methods for integrating multiple data streams to support critical safety investigations. Interested parties can coordinate through the CDER Acquisition Liaison.