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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Hands holding a question mark and lightbulb
The FDA found data integrity issues in BE studies at Raptim Research conducted between 2019 and 2023. (Shutterstock)
Key Takeaways
  • The FDA found data integrity issues with BE studies conducted by Raptim Research between 2019 and 2023.
  • The agency told the CRO about potential falsification of data from multiple skin donors in 2024 and has concerns about the reliability of its methods for in vivo studies.
  • The announcement came as Indian firms were required to register with its Central Licensing Authority, in part to help improve standards compliance.

The US Food and Drug Administration announced a new data falsification case just as contract research organizations faced new mandatory registration rules in India.

The agency said it found “significant data integrity and study conduct concerns” in bioequivalence studies conducted between 2019 and 2023 at CRO Raptim Research, based in Navi Mumbai, India.

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