A comparative analysis of quality management standards for contract research organisations in clinical trials
International Journal of Health Care Quality Assurance
ISSN: 0952-6862
Article publication date: 13 February 2007
Abstract
Purpose
This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants.
Design/methodology/approach
Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials.
Findings
The paper concludes that the ISO 9000 series of quality standards can act as a company‐wide framework for quality management within such organisations by helping to direct quality efforts on a long‐term basis without any loss of compliance.
Originality/value
This study is valuable because comparative analysis in this domain is uncommon.
Keywords
Citation
Murray, E. and McAdam, R. (2007), "A comparative analysis of quality management standards for contract research organisations in clinical trials", International Journal of Health Care Quality Assurance, Vol. 20 No. 1, pp. 16-33. https://doi.org/10.1108/09526860710721196
Publisher
:Emerald Group Publishing Limited
Copyright © 2007, Emerald Group Publishing Limited