Sentinel: Sentinel System Data Platform BPA

The Sentinel System 3.0 (OY1) is a single, multiple-award, tiered contract designed to establish a new Data Hub that enables the Food and Drug Administration to access and analyze diverse real-world data sources for postmarket safety monitoring. This initiative fulfills mandates under the Food and Drug Administration Amendments Act (FDAAA), which requires the FDA to develop robust methods for integrating and analyzing safety data from disparate systems to support Active Postmarket Risk Identification and Analysis (ARIA). The Data Hub will serve as a central platform for linking and evaluating real-world evidence across medical products regulated by CDER, ensuring timely identification of potential safety signals and informed risk management decisions. Funding for this effort draws from multiple sources including BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds, reflecting the broad and critical nature of the program’s objectives. The contract, officially titled Sentinel: Sentinel System Data Platform BPA, is forecasted for release with a posted date of May 25, 2026, and falls under the NAICS code 541690 for other scientific and technical consulting services. Responsibility for acquisition is managed by the FDA’s Center for Drug Evaluation and Research, with the Program Point of Contact listed as the Cder Acquisition Liaison at cderacquisitions@fda.hhs.gov, while the Contracting Officer position remains to be determined. The place of performance has not been specified, indicating a flexible, potentially remote or distributed operational structure to serve national FDA needs.