A comparative analysis of quality management standards for contract research organisations in clinical trials.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
This study is valuable because comparative analysis in this domain is uncommon.
Murray
Elizabeth
E
Bio-Kinetic Europe Ltd, Belfast, UK.
McAdam
Rodney
R
D002986:Clinical Trials as Topic / Q000592:standards*; D003284:Contract Services / Q000458:organization & administration / Q000592:standards*; D004345:Drug Industry / Q000458:organization & administration / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D008330:Management Audit; D017749:Total Quality Management / Q000458:organization & administration / Q000592:standards*