Document Detail


A comparative analysis of quality management standards for contract research organisations in clinical trials.
MedLine Citation:
PMID:  18240505     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Elizabeth Murray; Rodney McAdam
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International journal of health care quality assurance     Volume:  20     ISSN:  0952-6862     ISO Abbreviation:  Int J Health Care Qual Assur     Publication Date:  2007  
Date Detail:
Created Date:  2008-02-04     Completed Date:  2008-02-19     Revised Date:  2011-08-25    
Medline Journal Info:
Nlm Unique ID:  8916799     Medline TA:  Int J Health Care Qual Assur     Country:  England    
Other Details:
Languages:  eng     Pagination:  16-33     Citation Subset:  H    
Affiliation:
Bio-Kinetic Europe Ltd, Belfast, UK.
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic / standards*
Contract Services / organization & administration,  standards*
Drug Industry / organization & administration,  standards*
Humans
International Cooperation
Management Audit
Total Quality Management / organization & administration,  standards*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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