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Thrapston, Kettering Northants NN14 4ZL
Copyright © 2008 Qualogy Ltd
As a result of the EU Clinical Trials Directive and subsequent promulgation of laws in EU member states covering the conduct of clinical trials in accordance with Good Clinical Practice (GCP), there is the need for laboratories undertaking analysis of samples from clinical trials to comply with these laws.The standard to be followed by such laboratories is not well defined in GCP and hence the development of GCLP which provides guidance on the standards anticipated.
The scheme involves the assessment of a clinical laboratory which undertakes the
analysis of samples from clinical trials, to assess compliance with the Good Clinical
Laboratory Practice (GCLP) standard, as published by the British Association of Research
Quality Assurance (BARQA), 2003 ISBN 1-
The scheme is aimed at those laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that the clinical laboratory operates to a standard that assures the reliability, quality and integrity of the work and results generated.
GCLP Training
Training courses are offered for staff working in laboratories that undertake the analysis of samples from clinical trials in the requirements, interpretation and application of GCLP. Courses are also offered to clinical trial monitors on the requirements to look for during the monitoring of clinical laboratories.
GCLP Audits
We conduct audits of analytical laboratories on behalf of study sponsors to assess the compliance of laboratories with study, GCP and GCLP requirements.
GCLP Compliance Assessment
If you are an analytical laboratory that undertakes the analysis of samples from clinical trials then we can undertake an assessment of your operations for compliance with the requirements of GCLP.
