IQVIA awarded FDA contract to expand biologic safety monitoring

07-Feb-2018 - Last updated on 19-Aug-2019 at 09:39 GMT

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IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).

IQVIA was selected and awarded two contracts in September 2017 after an open, competitive contracting process, explained Lorrie McNeill, director, Office of Communication, Outreach and Development, FDA CBER.

As part of the agreement, IQVIA — formerly QuintilesIMS — will monitor and assist in the evaluation of safety and effectiveness of CBER-regulated vaccines, blood products, and other biologics.

The agreement also marks the launch of CBER’s Biologics Effectiveness and Safety (BEST) Initiative, a component of the Sentinel Initiative, which was launched in May 2008. The Sentinel is the FDA’s national electronic system for monitoring the safety of FDA-regulated medical products.

The BEST Initiative “continues CBER’s public health efforts to develop new active postmarket risk identification and analysis systems in Sentinel to better address surveillance and epidemiological study needs unique to regulated biologic products,” McNeill told us.

To further support the collaboration, IQVIA has teamed up with the Observational Health Data Science and Informatics (OHDSI) initiative and its established international network of researchers and observational health databases.