Advertisement
ProteinSimple
ProteinSimple

CRO Fakes Research

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

By | July 28, 2011

FLICKR, HOBVIAS SUDONEIGHM

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 at the time those studies were conducted, and possible evidence that the company was neglecting to report failed results or positively “fixing” studies to achieve a desired outcome.

Though the FDA noted that “at this time,  there is no evidence of problems with the safety, quality, purity or potency of drugs already approved and marketed,” the agency is notifying companies that have used Cetero-generated data collected between April 2005 and June 2010 in pending regulatory applications that they may need to be “evaluated and possibly redone,” due to the potential unreliability of the results.

Advertisement

Add a Comment

Avatar of: You

You

Processing...
Processing...

Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Popular Now

  1. Turning Tumor Cells Against Cancer
  2. Neanderthals’ Genetic Legacy
  3. Brazil’s Pre-Zika Microcephaly Cases
    The Nutshell Brazil’s Pre-Zika Microcephaly Cases

    A review of four years’ worth of medical records finds far greater numbers of microcephaly cases from before the ongoing Zika virus epidemic than had been officially reported.

  4. The Mycobiome
    Features The Mycobiome

    The largely overlooked resident fungal community plays a critical role in human health and disease.

Advertisement
Advertisement
Life Technologies