FDA Issues Contract Awards for Sentinel System

Today the Food and Drug Administration (FDA) awarded the third five-year contract for the Sentinel System, one of FDA’s premier evidence generation platforms to advance FDA’s mission to ensure the safety and effectiveness of FDA approved medical products. The new contract was awarded to two consortiums led by Harvard Pilgrim Health Care and Deloitte Consulting to oversee three distinct coordinating centers. The Sentinel Operation Center and Innovation Center contracts were awarded to Harvard Pilgrim Health Care. The contract for the Community Building and Outreach Center was awarded to Deloitte Consulting.

The Operations Center will leverage organizational partnerships to build and maintain a diverse team with expertise in epidemiology, clinical medicine, pharmacy, statistics, health informatics, data science (specifically, artificial intelligence (natural language processing, machine learning)), network operations, and training to achieve the goals of this requirement. The Innovation Center will develop innovative methods to further evolve the Sentinel System, including exploring novel ways to extract and structure information from electronic health records in the future. The Community Building and Outreach Center’s will focus on communication and collaboration as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel System tools and data infrastructure.

Prior to awarding the contracts, stakeholders had multiple opportunities to interact with FDA on Sentinel.

• December 2017, FDA issued a Request for Information to capture insights that could help the Sentinel System to address current challenges, promote efficiency, and support the anticipated needs around efficient chart review, accessing electronic health record data, and separating core operations from methods development.
• April 2018, FDA held an Industry Day to collect market research about new capabilities that might inform the Sentinel System contract.
• January 2019, FDA published the “Sentinel System 5-Year Strategy 2019-2023”, to provide FDA’s current thinking on the future aims, objectives, and goals of Sentinel.
• March 2019, FDA held a Pre-Proposal Forum to review the solicitation process, share important contract timelines, and provide a forum for potential offerors to ask questions and better understand the contract requirements
• April 2019, FDA held the 11th annual Sentinel public workshop to share updates on FDA’s plans to realize the vision in the Strategic Plan. FDA broadly advertised the request for proposals for the Sentinel contract.