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Gottlieb Takes Aim At CROs’ ‘Outdated Processes’ In Push For Clinical Trial Digitization

 
• By Sue Sutter

Better use of digital tools to capture – and audit – data can help lower developmental costs, US FDA commissioner says, urging a move away from manual processes ‘perpetuated by entrenched players like contract research organizations that profit off the old ways of doing things.’

An archer with bow takes aim at target

US FDA Commissioner Scott Gottlieb is taking aim at contract research organizations, and what he calls their outdated practices, in pushing to bring drug development and regulation fully into the digital age.

In prepared remarks delivered at a Reagan-Udall Foundation meeting on expanded access Nov. 19, Gottlieb talked about opportunities to improve the efficiency and quality of clinical trials by making better...

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