Sentinel: Sentinel System Studies Order

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 meet FDAAA mandates for the Active Postmarket Risk Identification and Analysis system by creating a centralized hub that provides access to diverse data sources and associated analytic support services. The primary goal is to develop validated methods for linking and analyzing safety data from multiple sources to support investigations for all CDER medical products. This forecast falls under NAICS code 541690 and utilizes a variety of funding streams, including BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds, to leverage real-world data. The project is managed by the Food and Drug Administration, with the Cder Acquisition Liaison serving as the primary program point of contact.