Author: Jane Edwards|| Date Published: September 12, 2018
Four companies have each won a potential five-year, $75M contract to provide the Food and Drug Administrations center for biologics evaluation and research with data, tools and infrastructure for use in the surveillance of vaccines, tissues, blood products and other biologics.
The contractors will provide the FDA with indirect 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.
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