Definitive Contract 75F40126C00029
- Not listed
- This is a delivery order contract awarded by the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to Harvard Pilgrim Health Care Inc.'s Office of Sponsored Programs division, a non-profit organization. The $41,709,751.95 contract is for the FY16 SENTINEL INFRASTRUCTURE, METHODS & SURVEILLANCE project and has a completion date of October 1, 2023. The contract is a Firm Fixed Price (FFP) award and does not have a set-aside designation. Harvard Pilgrim...
- This is a firm-fixed-price delivery order contract awarded by the Food and Drug Administration (FDA) to Harvard Pilgrim Health Care Inc.'s Office of Sponsored Programs Division, a non-profit healthcare organization. The $1,954,662.05 contract supports the FDA's Sentinel Initiative for post-market medical product safety surveillance, involving activities such as maintaining and enhancing the Sentinel system. Harvard Pilgrim leverages its expertise in healthcare data analytics, epidemiology, and...
- The Department of Health and Human Services Food and Drug Administration awarded a $16.4 million delivery order contract to Harvard Pilgrim Health Care Inc. Office Of Sponsored Programs Division to provide services supporting the enhancement and sustainment of the Sentinel System through the expansion of the National Electronic Active Post-Market Risk Identification and Analysis System and real world evidence capabilities. The contract has a period of performance from August 18, 2023 through...
- The Food and Drug Administration (FDA) awarded a $9.7 million delivery order contract modification to Harvard Pilgrim Health Care Inc. on March 29, 2024, to support the Sentinel System's PDUFA VII commitment for pregnancy safety demonstration projects and negative control tool development. This modification (MOD P00004) adds $1 million to Line 12 of the contract to maintain mother and infant record linkages across a subset of Sentinel Data Distributed (SDD) partners, including conducting...
- This federal contract award was made by the Food and Drug Administration (FDA) to Harvard Pilgrim Health Care Inc., a non-profit healthcare organization based in Canton, Massachusetts. The $5,125,868.18 contract is a Delivery Order under a Time and Materials pricing type, with a period of performance through September 29, 2025. The contract is for the Sentinel Innovation Center (IC) project, which involves refining the master plan, onboarding electronic health record (EHR) data partners,...
- This is a $4,039,999.68 firm fixed-price delivery order awarded by the Food and Drug Administration (FDA) to Harvard Pilgrim Health Care Inc. to provide a "Rapid Safety Surveillance Capability." The work supports the FDA's Sentinel Initiative, which monitors the post-market safety of medical products through electronic healthcare databases. As a non-profit organization, Harvard Pilgrim leverages its expertise in health data analytics, epidemiology, and program management to maintain...
- The Department of Health and Human Services Food and Drug Administration awarded a $114 million firm fixed price delivery order contract to Harvard Pilgrim Health Care Inc. Office of Sponsored Programs Division. The contract is for the Sentinel Initiative-Operations Center and will utilize the prime contractor's expertise in data analytics and operations center management to support the FDA's post-market safety surveillance program through December 2024. Performance will take place in...
- This $565,000.00 firm fixed-price delivery order contract was awarded by the Department of Health and Human Services Food and Drug Administration to Harvard Pilgrim Health Care Inc., a non-profit health care organization. The contract is for OCET/SENTINEL ACTIVITIES, which likely refers to post-market safety monitoring of medical products and enhancing vaccine safety surveillance, based on Harvard Pilgrim's experience supporting the Food and Drug Administration's Sentinel Initiative and the...
- This is a Delivery Order contract awarded by the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to Harvard Pilgrim Health Care Inc., a non-profit healthcare organization. The contract, with a potential value of $1,785,422.40, is for the development of an empirical method to automate negative control identification in the FDA's Sentinel post-market surveillance system. The contract has a period of performance through September 30, 2027 and uses a Time and...
- This is a delivery order contract awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services (HHS), to Harvard Pilgrim Health Care Inc. The $1,521,175.83 firm fixed-price contract is for the "CDER Evaluation of Potential Exposure/Outcome Associations" task order, which is part of a larger effort supporting the FDA's Sentinel Initiative for post-market medical product safety surveillance. Harvard Pilgrim, a non-profit...
The Food and Drug Administration (FDA) awarded a $31.7 million firm fixed-price definitive contract to Harvard Pilgrim Health Care Inc. on March 29, 2026, with an ultimate completion date of September 28, 2027. The SENTINEL 2.0 Bridge Contract will be performed in Canton, Massachusetts, and represents a continuation of work supporting the FDA's Sentinel System, which conducts post-market medical product safety surveillance. This contract does not utilize a set-aside designation. Harvard Pilgrim Health Care Inc., a non-profit healthcare organization with expertise in epidemiology, pharmacoepidemiology, and health informatics, will leverage its Office of Sponsored Programs Division to support critical national health initiatives focused on identifying and monitoring safety risks associated with FDA-regulated products. The Sentinel System is a cornerstone of the FDA's pharmacovigilance infrastructure, enabling the agency to conduct large-scale, real-world safety analysis of medical products including pharmaceuticals, biologics, and medical devices. Harvard Pilgrim Health Care Inc. brings substantial experience to this engagement, having previously supported the Sentinel System through multiple contract vehicles and demonstrating proven capabilities in developing empirical risk identification methodologies and conducting epidemiological research. The bridge contract ensures continuity of these critical safety surveillance operations while supporting the FDA's ongoing mission to protect public health through sophisticated data analysis and research-driven decision making.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $10.5m | 3/25/26 |