LEXINGTON, Ky., July 19 /PRNewswire/ -- REGISTRAT(R), Inc. (REGISTRAT), leading Late Phase Clinical Research Organization (CRO) providing services for the biopharmaceutical and medical device industry, has announced the appointment of Peggy McHugh as Vice President, Strategy and Development. Ms. McHugh adds her extensive experience in the biopharmaceutical sector to REGISTRAT, where she will focus on strategic oversight and direction for clinical studies conducted by the company.
"The addition of Peggy to our Senior Management Team further emphasizes the strategic approach REGISTRAT provides clients to design registries and clinical studies in the peri-approval period of the product life cycle," said Ronald A. Christensen, M.D., President of REGISTRAT. "In addition to assisting sponsors to optimize clinical and commercial benefits that contribute to a successful product launch and support ongoing commercialization efforts, Peggy will provide valuable input regarding the company's strategic direction, planning, resourcing, and ongoing initiatives."
Ms. McHugh brings over 17 years experience managing projects in Phases I- III, IIIb, and IV, post-marketing studies, and patient registries in excess of 10,000 patients. She developed Medical Affairs and Clinical Operations departments and participated in the realignment of a Safety Surveillance group. Activities included recruiting, training, and supervising Clinical Directors, Medical Affairs Managers, and CRAs. Ms. McHugh's former employers include Intermune (Senior Director, Clinical Operations), Amgen (Director, Medical Affairs), Immunex, (Director, Clinical Trials), Rhone-Poulenc-Rorer (Senior Research Specialist), and hospitals, medical centers, and universities where she started her career as a nurse and clinical instructor. She has been a guest lecturer/faculty member of PERI since 1995 and was Co-Course Director for the Basic Training in Clinical Monitoring Course.
"Peggy is a highly valued addition to our company," reports Stephen Webb, Executive Vice President of REGISTRAT. "We are very enthusiastic about Peggy's ability to help us meet our clients' expectations to work with professionals who understand their scientific and marketplace issues to build mutually rewarding long-term partnerships."
Late Phase (peri-approval) studies are conducted prior to product approval (Phase IIIb) and following product launch (Phase IV) to demonstrate product effectiveness, safety, and acceptance. Increasingly, the FDA is granting product approval on a conditional basis -- requiring that a sponsor conduct post-approval surveillance of the product. Managed care organizations, health care providers, and consumers all have an interest in "real-world" clinical and health economic outcomes data and its contribution to improved patient care.
REGISTRAT is a leading full-service CRO provider of Late Phase services.Phase IIIb-IV clinical studies, patient registries, post-marketing studies, safety surveillance, risk management programs, and patient reported outcomes. REGISTRAT services are tailored specifically to each study and combine state-of-the-art technologies, applications, and approaches to promote ease-of-use, efficiencies, and cost effectiveness. The company is headquartered in Lexington, Kentucky, and can be found on the Web at www.registrat.com.
REGISTRAT, Inc.CONTACT: Myrna Hale of REGISTRAT, Inc., +1-859-223-4334, ext. 480
Web site: http://www.registrat.com/
