STEVENAGE, England--(Novella Clinical, a full service clinical research organization, today announced Karen Kelso, Ph.D., has joined as regulatory affairs director. Focused on cardiovascular medical devices, Dr. Kelso has extensive regulatory experience in global markets for all medical device classifications (I, IIa, IIb and III).)--
“Karen’s regulatory experience in the U.S., Europe and Asia and her relationships with international agency officials will greatly benefit Novella’s medical device clients, many of whom are seeking to expand clinical trials to international markets.”
Supporting Novella’s global medical device practice, Dr. Kelso will drive regulatory and clinical strategy for multinational programs. Having achieved dozens of CE Marks, she has also written, submitted and cleared multiple 510(k)s with the FDA. Her experience also includes several pre-IDE submissions and IDE approvals.
Dr. Kelso comes to Novella Clinical after a sixteen-year career at Vascutek, a Terumo Company, in Scotland, where she most recently served as vice president regulatory affairs and clinical studies for the company’s portfolio of vascular products. She formerly held positions in research and development.
Novella Clinical’s Global Head of Regulatory Affairs, Kevin Johnson, noted, “Karen’s regulatory experience in the U.S., Europe and Asia and her relationships with international agency officials will greatly benefit Novella’s medical device clients, many of whom are seeking to expand clinical trials to international markets.”
Dr. Kelso holds a Ph.D. in biochemistry from Glasgow University, where she also earned a B.Sc. with Honors in Applied Animal Science. She holds a B.A. in Science, Human Health and Genetics from Open University in the United Kingdom and a Higher National Diploma in Biotechnology.
About Novella Clinical
Novella Clinical, Inc. is a full service clinical research organization with dual headquarters in Research Triangle Park, N.C and Stevenage, England. Celebrating its 15th anniversary, Novella serves as an active partner to the oncology, biopharma and medical device industries. As the first global eCRO, Novella integrates deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process. For more information, visit www.novellaclinical.com.