CRO Fakes Research

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

Written byJef Akst

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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 (an unusual nickname for Jennifer) got her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses. After four years of diving off the Gulf Coast of Tampa and performing behavioral experiments at the Tennessee Aquarium in Chattanooga, she left research to pursue a career in science writing. As The Scientist's managing editor, Jef edited features and oversaw the production of the TS Digest and quarterly print magazine. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers.
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