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Data Integrity ‘More Than Just A GMP Issue’ As Attention To Clinical, Nonclinical Lapses Grows

 
• By Sue Sutter

Sponsors should notify US FDA quickly when they detect data quality issues in preclinical and clinical research, particularly for applications under review, experts say in a rebuke to Novartis’ delayed notification about Zolgensma data manipulation.

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Corporate compliance programs should be capable of detecting GCP and GLP data integrity violations. • Source: Shutterstock

Data integrity lapses in preclinical and clinical research can endanger a drug development program and warrant close attention from sponsors as well as early communication with the US Food and Drug Administration, industry lawyers and consultants say.

While data integrity issues in the pharmaceutical manufacturing space, including warning letters and enforcement actions for good manufacturing practice (GMP)...

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