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Lee Truax-Bellows


Lee Truax-Bellows

Norwich Clinical Research Associates Ltd. (NCRA)
USA

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).

Abstract

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