Cetero Reaches Final Resolution with the Food and Drug Administration
Cary, NC – (April 24, 2012) – Leading early-phase Contract Research Organization (CRO) Cetero Research today announced it has reached a final resolution with the U.S. Food and Drug Administration (FDA) over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 through June 15, 2010. Following months of open collaboration between Cetero and the FDA, the Agency recently summarized its final decision on the disposition of studies from the time periods in discussion, specifically:
• Studies performed between September 1, 2009 and June 15, 2010: The Agency will accept studies for submission and review without reanalysis, repeating, or further audit by Cetero or a third party.
• Studies performed between March 1, 2008 and August 31, 2009: The Agency will accept studies for submission and review if the studies are accompanied by an independent third-party data integrity audit. Further, studies that were previously submitted as part of an approved or pending application will also need verification of data integrity by an independent third-party audit.
• Studies performed between April 1, 2005 and February 28, 2008: Studies that were previously submitted as part of an approved or pending application, or studies that will be submitted as part of a new application, will need complete reanalysis (if stable samples exist) or repeat of the study.
"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 Dr. Troy W. McCall, CEO of Cetero. "This final notification marks the completion of more than eight months of successful collaboration between Cetero and various divisions within the FDA."
"From the time Cetero discovered the incident through our own investigation and self-reported the issues directly to the FDA, to the lengthy internal investigation that followed in which updates were regularly provided to the FDA, to the FDA review and recent final resolution, we have taken this matter very seriously," said Dr. McCall. "We continue to support, as we always have, the FDA's mandate to ensure the health and safety of the American public, and share a deep sense of responsibility in our important role towards accomplishing that goal. State‐of‐the‐art systems have been established to the satisfaction of the FDA and Cetero that verify the integrity of study data and allow us to set the gold standard for regulatory compliance."
About Cetero Research
Cetero Research, the leading early-phase contract research organization (CRO), has conducted more than 20,000 clinical pharmacology studies, more than any other CRO. With facilities across North America, Cetero offers flexible, high-quality clinical development services in a range of therapeutic areas, including asthma and allergy, dermatology and diabetes, as well as bioanalytical services to support clinical, preclinical drug and biomarker analysis for small and large molecules. It uses innovative approaches, such as the Accelerated-Proof-of-Concept study design, to provide key decision-making data earlier in the development process. A pioneer in the pharmaceutical and biotechnology space, Cetero prioritizes ensuring the safety of its patient and normal healthy study participants, reporting high-quality, reliable data and providing on-time results. For more information, visit www.cetero.com or call 877.7CETERO.
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For more information, please contact:
April Johnson
Vice President, Business Relationship Management
Cetero Research
Direct Line: 919-468-4214
Email: [email protected]