Sentinel: Sentinel System Studies Order

The contract involves the Sentinel System 3.0 (OY1), which is designed to establish a new 'Data Hub' that will enable the FDA to access and analyze a wide variety of data sources in support of active postmarket risk identification and analysis, as mandated by the FDA Amendments Act (FDAAA). This system will facilitate the linking and examination of safety data from multiple disparate sources, addressing the requirement for validated methods to support comprehensive safety evaluations of medical products under the Center for Drug Evaluation and Research (CDER). The contract is structured as a single, multiple-award, tiered agreement to provide both access to diverse data streams and the necessary analytic support services. Funding for this contract is derived from multiple sources including Base Appropriations, Real-World Evidence budgets, and specific user fees such as PDUFA, GDUFA, BSUFA, as well as the 21st Century Cures Act Real-World Evidence funds, reflecting the broad application of real-world data in postmarket surveillance efforts. The contract falls under NAICS code 541690, indicating a focus on scientific research and development services, and is managed by the FDA with a program point of contact available via the Center for Drug Evaluation and Research acquisitions team. The solicitation is forecasted for 2026, aiming to ensure continuity and enhancement of the Sentinel System’s capabilities to meet evolving regulatory and safety monitoring needs.