Lee Truax-Bellows
Norwich Clinical Research Associates Ltd. (NCRA)
USA
Title: The impact of a quality system approach on outsourcing and conduct of clinical research trials
Biography
Biography: Lee Truax-Bellows
Abstract
As anyone in the business can attest to, the conduct of regulated clinical research continues to evolve. Several reasons for this evolution is based on 1) lessons learned over the years, 2) a continuing shift of clinical trial expectations from a regulatory perspective and 3) the advent and progression of electronic communication and documentation. With this evolution come both old and new issues that arise during the conduct of the trials. This session will focus on the impact of this evolution on the preparation, management and conduct of clinical research trials and provide an overview of why developing and using a robust Quality System Management approach has become a necessity for the conduct of regulated clinical trials.
