Cetero Research, the North Carolina clinical research organization that fell under a U.S. Food and Drug Administration probe this year for allegedly falsifying data, has made two new hires that should help the CRO maintain regulatory compliance.
Michael Fillios is now chief administrative officer for the Cary, North Carolina company. David Coggin has been named vice president of biometrics. Both positions report directly to Cetero CEO Troy McCall. In a statement, McCall said that the hirings of Fillios and Coggin will help Cetero “realign infrastructure and integrate service offerings” to serve its customers.
The FDA disclosed in July an inquiry into Cetero that raised questions about the CRO’s work and test results over a five-year period. The FDA later shortened that period by a year and said that information collected by the agency and provided by Cetero demonstrated that the company implemented appropriate procedures after Sept. 1, 2009.
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The FDA said its inspection of Cetero’s Houston site found “widespread falsification of dates and times in laboratory records for subject sample extractions, and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.” Cetero attributed the discrepancies to workers trying to claim overtime. The agency has urged pharmaceutical companies that have done work with Cetero to verify their data.
Cetero focuses on early stage clinical research. This early testing of how what a drug does to the body and how the body processes a drug is key to helping pharmaceutical companies determine how to proceed with a drug development program. Cetero claims that the more than 20,000 clinical pharmacology studies that it has conducted are more than any other CRO.
Coggin will oversee management of pharmacokinetic and pharmacodynamic operations, data management, biostatistics and medical writing. Coggin has 17 years experience at Covance (NYSE:CVD), where he was most recently the CRO’s global head, early clinical services and clinical data management. Fillios comes to Cetero from engineering and manufacturing company ITT Corporation. He will oversee human resources, IT, project management and marketing and client services.
