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The Case Of The Suspect Spreadsheet: Semler Sues US FDA Over Data Integrity Concerns

 
• By Sue Sutter

India-based CRO alleges FDA 'annihilated' its business with announcement that sponsors must re-do bioequivalence and bioavailability studies; Semler asserts invalid or falsified study data were never submitted to the agency and FDA's conclusions rest upon a 'suspect spreadsheet' created by a 'rogue employee.'

business documents accounting with calculator and magnifying glass. concept for financial

A contract research organization alleges the US FDA's decision to make public what the CRO says are unfounded claims about data fraud destroyed its reputation and damaged its business.

In a lawsuit, India-based Semler Research Center Private Ltd. (SRC) alleges it has sustained approximately $50m in damages, in the...

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