Four Firms to Provide Data Sources, Tools for FDA’s Biologics Surveillance Effort

Four companies have each won a potential five-year, $75M contract to provide the Food and Drug Administration™s center for biologics evaluation and research with data, tools and infrastructure for use in the surveillance of vaccines, tissues, blood products and other biologics.

A FedBizOpps notice posted Monday says IBM (NYSE: IBM), Acumen, Dovel Technologies and IQVIA Government Solutions will perform work at their respective facilities in support of CBER™s Biologics Effectiveness and Safety program.

The contractors will provide the FDA with œindirect access to a network of electronic health records and other data of U.S. patients through a distributed data framework and build a data infrastructure to help the agency run observational studies and queries related to CBER-regulated biologics, according to the solicitation.

The BEST initiative also includes the development of semi-autonomous methods to facilitate reviews of medical charts.

The indefinite-delivery/indefinite-quantity contracts cover three other tasks: queries and epidemiological studies; operations and management; and outreach and communications, according to the statement of work.

Sponsor