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Data Integrity: COVID-19 Impacted Studies Pose Unique Enforcement Risks

 
• By Sue Sutter

Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.

Hand turning door knob
When it comes to reporting CRO misconduct, the first pharma sponsor through the door gets more consideration from DoJ than the second. • Source: Alamy

As the US Food and Drug Administration and Department of Justice continue to make clinical trial data integrity an enforcement priority, COVID-19-impacted studies may pose unique risks in this regard.

The move toward decentralized trials spurred by the pandemic is a “very exciting development” but one that brings its own...

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• By Neena Brizmohun

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.