Sentinel: Sentinel System 3.0 Data Hub / Data Partners IDIQ

The Sentinel System 3.0 Data Hub contract is designed to support the FDA’s mandate under the FDAAA to establish an Active Postmarket Risk Identification and Analysis system by creating a centralized data infrastructure that integrates disparate real-world data sources and provides advanced analytical capabilities. This multiple-award, tiered IDIQ will enable the FDA to access, link, and analyze safety data across a broad spectrum of medical products regulated by CDER, leveraging real-world evidence to enhance postmarket surveillance and risk evaluation. The Data Hub will serve as the foundational platform for identifying and evaluating potential safety signals using validated methods and standardized protocols across diverse data ecosystems. Funding for this initiative is drawn from multiple sources including BA, BA RWE, PDUFA, GDUFA, BSUFA, and the 21st Century Cures Act RWE funds, reflecting the comprehensive nature of the FDA’s postmarket safety obligations. The contract supports a network of qualified data partners who will contribute secure, compliant, and scalable data access and analytical services. The NAICS code 541690 indicates a focus on other scientific and technical consulting services, aligning with the technical and analytical demands of the project. The program point of contact is the CDER Acquisition Liaison, with the contracting officer position to be determined, and the forecast was posted in May 2026 through the HHS OSDBU platform, signaling the upcoming formal solicitation process for potential contractors.