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

Elizabeth Murray, Rodney McAdam

    Research output: Contribution to journalArticlepeer-review

    4 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)16-33
    Number of pages18
    JournalInternational Journal of Health Care Quality Assurance
    Volume20
    Issue number1
    DOIs
    Publication statusPublished - 2007

    Keywords

    • Best practice
    • Northern Ireland
    • Pharmaceuticals industry
    • Product trials
    • Quality management
    • Standards

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