Sentinel: Sentinel System Studies Order

The Sentinel System 3.0 (OY1) is a new multiple-award, tiered contract designed to support the continuity of the FDA’s Sentinel Initiative by establishing a centralized Data Hub that enables access to diverse real-world data sources and provides advanced analytic services. This initiative fulfills requirements under the FDAAA, which mandates the FDA to develop the Active Postmarket Risk Identification and Analysis system to link and analyze safety data across multiple disparate sources, ensuring robust postmarket surveillance of medical products. The Data Hub will serve as the technical and operational backbone for this effort, facilitating the integration and analysis of real-world evidence to support decision-making across all CDER-regulated products. Funding for this contract draws from multiple authorized sources including BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds, reflecting the broad scope and critical nature of real-world evidence in postmarket safety monitoring. The solicitation is forecasted with a NAICS code of 541690, indicating it falls under other scientific and technical consulting services, and is managed by the Food and Drug Administration. The primary point of contact for program inquiries is the Cder Acquisition Liaison, while the Contracting Officer position remains to be determined. The contract opportunity is publicly forecasted through the HHS OSDBU portal, with no set-aside designation specified, and performance is expected to be nationwide without a defined place of performance.