CRO Fakes Research

FDA points its finger at an early-stage contract research organization for falsifying documents and manipulating samples.

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Cetero Research, a North Carolina-based early-stage contract research organization, faked documents and manipulated samples, according to three sources: two US Food and Drug administration inspections, an internal company investigation, and a third-party audit. As a result, the FDA has warned that drug companies who have used Cetero’s services may have to reevaluate their results, Reuters reports.

“The inspections and audit identified significant instances of misconduct and violations of federal regulations” at Cetero’s bioanalytical facility in Houston, Texas, the FDA said on Tuesday (July 26). "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame."

The investigations uncovered nearly 2,000 studies in which the overseeing lab technicians were not present at Cetero facilities ...

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Meet the Author

  • Jef Akst

    Jef Akst was managing editor of The Scientist, where she started as an intern in 2009 after receiving a master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses.
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