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UCL ECMC GCLP Facility

The UCL ECMC GCLP Facility is a standalone facility, located on the ground floor of the UCL Cancer Institute, specifically designed for the purpose of clinical trial sample handling analysis and storage. The Facility operates to the principles of GCLP in order to ensure that all work for clinical trials is carried out in accordance with the current MHRA regulations, from translational experiments, through method development and validation, to clinical trial sample analysis.

The UCL ECMC GCLP Facility supports over 20 trials. The early phase trials portfolio includes UCL, CRUK and commercially sponsored trials in multiple modalities including chemotherapy, radiotherapy and immunotherapy.

The Facility has Full Accreditation in Good Clinical Laboratory Practice (Accreditation number 06519, Qualogy 2002 Ltd).  Good Clinical Laboratory Practice (GCLP) is a quality system for laboratories that analyse samples from Clinical Trials in accordance with Good Clinical Practice (GCP) regulations. Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and data reporting of clinical trials that provides assurance that the data and the reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

The Cancer Research UK Centre for Drug Development Biomarker Centre was awarded to the GCLP Facility in 2017 upon tender bid between national ECMCs. The Biomarker Centre has the aim of developing and validating novel biomarker assays for early phase clinical trials with the use of pharmacodynamic and stratification biomarker technologies to identify and progress new treatments for the patients benefit.

The Facility is aligned with the NIHR UCLH Clinical Research Facility and UCLH Macmillan Cancer Centre, where patients are supported throughout their involvement in clinical research. This alignment enables ease of transfer of clinical trial samples between laboratories following patient treatment, as well as supporting each site in their research.

The work conducted in the Facility is supported by:

 

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