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  • Saturday, April 20, 2024

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 “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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