Seasoned Veteran Brings Extensive Quality, Computer Systems and Regulatory Background to Imaging CRO
Boston, Mass., April 17, 2012 — WorldCare Clinical, LLC (WCC), a leading imaging CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today announced that Kenneth O’Brien has joined the organization as executive director of quality and regulatory affairs. In his role, 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, PhD, president of WorldCare Clinical, LLC. “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, O’Brien was responsible for quality system implementation and regulatory compliance for PAREXEL International, Perceptive Informatics, Phase Forward, and Domain Pharma. In the last 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. 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.
For more information on WCC’s regulatory services, visit http://wcclinical.com/our-expertise/#page-Regulatory-Expertise.
About WorldCare Clinical
WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH. With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit wcclinical.com.
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