Sentinel: Sentinel System 3.0 Data Hub / Data Partners IDIQ

The contract involves the development and support of the Sentinel System 3.0 Data Hub, a tiered, multiple-award indefinite delivery indefinite quantity (IDIQ) contract aimed at providing the FDA with broad access to various data sources along with analytic support services. This initiative is designed to fulfill the FDA's statutory mandate under the FDAAA to establish an Active Postmarket Risk Identification and Analysis (ARIA) system. The Data Hub will enable the linking and analysis of safety data from diverse sources, enhancing postmarket surveillance for medical products regulated by the FDA. Funding for this contract spans multiple sources, including base appropriations and real-world evidence funds from programs such as PDUFA, GDUFA, BSUFA, and the 21st Century Cures Act. The resources will support the integration and validation of real-world data to facilitate risk identification and support regulatory decision-making for Center for Drug Evaluation and Research (CDER) medical products. The contract is managed by the FDA, with designated points of contact for program acquisition and contracting.