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Central Laboratories and the Importance of an Effective Quality System

Central laboratories play a significant role in the clinical trials process by providing drug development companies with clean, combinable laboratory data, which can be analysed and reported in a timely and cost-effective manner, and which can undergo global regulatory review. Due to the critical nature of the data being generated, it is essential that data are accurate, reliable and reproducible.

So, how can a central laboratory assure its clients of the quality of the data being generated in its operation? The answer lies in the question: the laboratory must establish a quality assurance system. Establishing a quality system involves the implementation of a series of processes and procedures that standardise operations. For a quality system to be credible, it must be examined by an independent external party that is recognised as being competent in the assessment of such a system. These external parties will investigate the laboratory's compliance to a recognised quality standard or guideline and make a recommendation for registration.

There are many different quality standards and guidelines in existence that are recognised in industry. For central laboratories, some quality standards are compulsory depending on the location of operations, whilst other standards are optional and may be adopted by laboratories wishing to enhance their reputation for quality. All central laboratories based in the US are obliged to meet clinical laboratory improvement amendment (CLIA) and state requirements. Additionally, US laboratories, as well as any medical laboratory that handles patient samples which originate in the US, can choose to comply with the requirements of the College of American Pathologists (CAP). In Europe, Asia and Australasia, laboratories will typically aim to comply with the standards published by the International Organization for Standardization (ISO), or with good laboratory practice (GLP) requirements.


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By Clare O'Sullivan, Laboratory Manager at ICON Laboratories

Clare O'Sullivan is the Laboratory Manager at ICON Laboratories, Europe. She holds a BSc (Hons) and a Masters degree in Microbiology from the National University of Ireland, Cork. Prior to becoming Laboratory Manager, Clare worked as QA Manager for over four years in ICON Laboratories and Tibotec-Virco Ireland, now a division of Johnson and Johnson. During her career as QA Manager she gained experience in the implementation and maintenance of quality systems compliant with ISO 17025, CAP, EN45001, EN45004 and CLIA regulations in both European and US-based facilities.

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Clare O'Sullivan
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