News
September 15, 2008
MDCI Welcomes Karin Graefe as Senior Clinical Data Manager
Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry is pleased to welcome Ms. Karin E. Graefe as Senior Data Manager in its clinical services group.
Karin will assist emerging and established medical device firms and clinical trial sponsors to design and build clinical trial databases that will best support medical device clinical trial requirements for pre- and post-market needs. She will manage the development and programming of study specific reports, as well as oversee the review and cleaning of medical device clinical data.
"We are very pleased that Karin has joined the MDCI team. She brings a record of successful project leadership of both paper-based and web-based clinical data management processes, and will provide our clients with strategic guidance and tactical solutions to medical device clinical trial data management issues."
Karin brings over 13 years of experience in both medical device and pharmaceutical clinical trials. She began her career at Massachusetts General Hospital as a clinical research coordinator and has held progressively senior clinical data management positions since 1997 for companies such as AstraZeneca, Wyeth Research, Accenture, Phase Forward, and BattelleCRO. Her experience covers a broad range of therapeutic areas, including oncology, neurology, cardiology, infectious diseases, respiratory diseases and rare genetic disorders.
Karin graduated magna cum laude and holds a B.A. in Social Psychology from Wheaton College, where she was a member of the Phi Beta Kappa national honors society, and Psi Chi, the national honor society for psychology.
About MDCI
MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative "hands-on" solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
Contact MDCI for more information about our medical device expertise.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.