FDA Awards Contract to Advance Drug Safety System

FDA says it has awarded a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safety and effectiveness of drugs. The contract, which was awarded to two consortiums led by Harvard Pilgrim Health Care and Deloitte Consulting, will create two new Sentinel Coordinating Centers: the Sentinel Innovation Center and the Community Building and Outreach Center, FDA says. It will also “establish three distinct coordinating centers (the Sentinel Operations Center, Innovation Center and the Community Building and Outreach Center) to widen participation to a broader array of scientific expertise, translate new technologies from emerging fields such as data science and big data, create laboratories to develop new approaches to using electronic health records and cultivate a robust scientific community to uncover novel ways to leverage the system's core capabilities beyond drug safety,” an agency release says.