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O'Brien brings quality, computer systems and regulatory background to imaging CRO
April 18, 2012
By: Tim Wright
Editor-in-Chief, Contract Pharma
Kenneth O’Brien has been named executive director of quality and regulatory affairs at WorldCare Clinical, LLC, an imaging CRO. In his role, Mr. O’Brien will be responsible for all quality assurance and regulatory affairs operations, including ensuring regulatory compliance and computer system validation processes. “Ken brings a wealth of regulatory, pharmaceutical and quality systems experience, and we’re pleased to welcome him aboard,” said Richard Walovitch, Ph.D., president of WCC. “His extensive knowledge in planning and implementing complex business and quality systems will be invaluable, particularly as it relates to broadening our expertise in maximizing the precision and accuracy of independent assessments in clinical trials.” Prior to joining WCC, Mr. O’Brien was responsible for quality system implementation and regulatory compliance for PAREXEL International, Perceptive Informatics, Phase Forward, and Domain Pharma. In the past 15 years, he has implemented quality systems and provided regulatory support for multiple technologies, including imaging, IVRS/IWRS, EDC, clinical trial management systems, clinical data management systems, safety reporting systems, and web portal systems. Mr. O’Brien is a retired United States Marine Corps Reserve, Gunnery Sergeant. He served as an aviation communications and navigation technician for the Marine Corps’ Huey helicopter during his time in the Marines.
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