Healthy Skepticism Library item: 12922

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Murray E, McAdam R.
A comparative analysis of quality management standards for contract research organisations in clinical trials.
Int J Health Care Qual Assur 2007; 20:(1):16-33
http://www.ncbi.nlm.nih.gov/pubmed/18240505?dopt=Abstract

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:
Clinical Trials as Topic/standards* Contract Services/organization & administration Contract Services/standards* Drug Industry/organization & administration Drug Industry/standards* Humans International Cooperation Management Audit Total Quality Management/organization & administration Total Quality Management/standards*