13 February 2019
We are proud to announce that the routine laboratories in Fajara and Keneba, and the research laboratories in Basse have now all received full certification to GCLP!
GCLP represents Good Clinical Practice in the Laboratories. It is an international quality system for laboratories that receive, handle, manage, and analyse samples from Clinical Trials in accordance with global Good Clinical Practice (GCP) regulations. The laboratories subscribed to a certification scheme designed by Qualogy Ltd. UK, which involves the assessment of a clinical laboratory against the Good Clinical Laboratory Practice (GCLP) standard as published by the Research Quality Association. This guideline has been adopted by the World Health Organisation (WHO).
Compliance with and certification to GCLP demonstrates to sponsors, investigators, and funders of clinical trials, as well as government agencies and other customers worldwide that our laboratories operate to an acceptable and established standard that ensures patients’ safety and rights and maintains their confidentiality as well as assuring the reliability, quality, integrity and accuracy of the work and results produced. In addition, it also provides management and staff with confidence as to the compliance of their work with GCP.
This is a huge achievement for the Unit! The Unit had subscribed to the assessment scheme since 2011, and it was only the laboratories at the Fajara station that were fully certified. With the extension of scope to all 3 sites since 2018, there is now flexibility with clinical trials and needed laboratory support. Evaluation of clinical trial samples can be conducted by any suitable clinical laboratory at any of the Unit’s 3 sites!