Sentinel: Sentinel System 3.0 Data Hub / Data Partners IDIQ

Support program continuity. The Sentinel System 3.0 (OY1) includes a single, multiple-award, tiered contract for a new 'Data Hub' to allow FDA access to a broad range of data sources and associated analytic support services. FDAAA mandated FDA to establish an Active Postmarket Risk Identification and Analysis (ARIA) and requires the FDA to develop methods to obtain access to disparate data sources and validated methods for the establishment of a system to link and analyze safety data from multiple sources. The 'Data Hub' will address these FDAAA requirements. Fund Type Rationale: ARIA relies on the use of Real-World Data to support investigations for all CDER medical products. Therefore, this request includes BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds.

Estimated value

>= $50M and < $100M

Est. solicitation date

Sep 1, 2025

Anticipated award

Mar 1, 2026

• NAICS541690
• PSC541690