Following two inspections, an internal investigation and a third-party audit, the U.S. Food and Drug Administration confirmed this week that contractor, Cetero Research, has been faking documents and manipulating samples.
Cetero Research conducts early phase clinical research and bioanalytics for several drug manufacturers, all of whom are then able to use any reported results as supporting evidence when seeking drug approval from the FDA. The investigation into the business practices of a Cetero facility in Houston uncovered that the company was engaging in “significant instances of misconduct and violations.”
In fact, according to the FDA, “The pattern of misconduct was serious enough to raise concerns about the integrity of data Cetero generated during the five-year time frame.” The regulatory agency warned drug makers who used Cetero’s services may have to repeat or confirm any studies conducted by the research company between April 2005 and June 2010.
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