Nine months after the FDA released a scathing report on fake clinical research at Cetero Research, driving the CRO into bankruptcy protection, the two entities have reached détente. Cetero and the FDA have concluded a final resolution over the work undertaken at Cetero's Houston laboratory between 2005 and 2010.
Cetero says the FDA agreed to accept studies conducted between September 1, 2009 and June 15, 2010 for submission and review without further reanalysis or audit from Cetero. The FDA will also accept studies conducted between March 1, 2008 and August 31, 2009, as long as each one comes with a third party verifying the findings and integrity. However, the FDA did order that studies conducted between April 1, 2005 and February 28, 2008 and subsequently submitted will need a complete redo or at least a reanalysis, if stable samples exist.
"We are very pleased with the final outcome of this process and want to thank each and every one of our clients, employees, and the FDA for their continued diligence and professionalism as we worked through this unprecedented challenge," said Cetero CEO Troy W. McCall in a statement.
Even after the FDA released a harsh letter last summer accusing Cetero employees of falsifying data in studies conducted in Houston, the CRO soldiered on, working with the government body to verify and correct more than 1,000 questioned studies, as one Cetero executive told FierceCRO last month. But despite its efforts to correct mistakes, Cetero suffered nonetheless, and the CRO was forced to file for Chapter 11 bankruptcy protection in March. With a resolution now brokered, it looks like Cetero can get back to finding a new owner that can absolve its financial debt and try to get the CRO back on track.
- read Cetero's statement on the resolution
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