Journal of Clinical Trials
Open Access

The impact of a quality system approach on outsourcing and conduct of clinical research trials

International Conference on Clinical Trials

July 27-29, 2015 Orlando-FL, USA

Lee Truax-Bellows

Keynote: J Clin Trials

Abstract :

Learning Objectives:
1. Summarize current trends in clinical trial outsourcing
2. List a minimum of 3 potential problem areas for the conduct of clinical research trials
3. Describe a minimum of 3 reasons why quality system management has become an integral requirement for the conduct
of clinical trial research
As anyone in the business can attest to, the conduct of regulated clinical research continues to evolve. Several reasons for
this evolution are 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.

Biography :

Lee Truax-Bellows is a Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research
organization (CRO) based in upstate NY. She has an extensive background in the pharmaceutical and medical device industries, having worked for both industry
and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, GCP Trainer, and Regulatory and SOP Consultant. She
has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing, and SOP development and training on
regulated research and Good Clinical Practice. She is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech
Association and Society of Quality Assurance (SQA). She is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a
Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).