The GCP laboratories conduct sample processing and endpoint analysis for clinical trials of drugs (Investigational Medicinal Products; CTIMPs), producing high impact data that results in a clear benefit to patients. A clinical trial looks at the safety and/or efficacy of a medicine in humans and is subject to a high level of statutory regulation. The Medicines and Healthcare products Regulatory Agency (MHRA) govern and inspect the laboratories as per the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated regulations.
The GCP laboratories collaborate with national and international universities, NHS Trusts and companies to produce high impact clinical research that benefits the public by improving clinical practice.
The GCP laboratories encompass expertise in the collection, validation and analysis of clinical trial samples to Good Clinical Practice for laboratory standards, and provides numerous validated assays and technologies.
Bioanalytical Facility (BAF)
Academic lead Professor Saye Khoo; Lab Manager Dr Laura Else
The BAF supports diverse clinical studies ranging from small Phase 0-1 first-in-man studies, to large multicentre randomised clinical trials funded by the UK Medical Research Council, UK National Institute of Health Research Wellcome Trust, Bill & Melinda Gates Foundation, US National Institute of Health, and the pharmaceutical industry.
High-sensitivity measurement of drugs in CSF, semen, breast milk, tissue biopsies, cervicovaginal and rectal fluid, peripheral blood mononuclear cells are exclusively performed using validated mass spectrometric methods.
BAF have had a successful MHRA inspection (February 2017) as part of a sponsor audit (SSAT 055), and are GCLP accredited by Qualogy.
Antimicrobial Pharmacodynamics Therapeutics (APT)
Academic lead Professor William Hope; Lab Manager Dr Jenny Unsworth
The APT provides preclinical and early phase clinical support to ensure new drugs are developed in a streamlined manner. The APT provides a complete, integrated drug development package, including state-of-the-art facilities for pharmacokinetic analysis and advanced PK-PD mathematical modelling of clinical trial data.
GCP Laboratory Facility (GCPLab)
Academic lead Professor Bill Greenhalf; Lab Manager Ms Lara Lavelle-Langham; Senior Biobank Manager Dr Mel Oates
GCPLab conduct samples processing and storage for a large number of clinical trials (~30). The GCPLab has several validated assays to analyse samples to the highest standard. These assays are carried out using a variety of platforms, such as clinical analysers, real-time PCR, ELISA, radionucleotide incorporation assays, Luminex® assays, FAC analysis and immunohistochemistry. The GCPLab is also a service provider for the RLBUHT Clinical Research Unit, Clattterbridge Cancer Centre (CCC) and pharmaceutical companies such as Janssen.
Biobanks managed through the GCPLab include:
- UK CLL Trials Biobank
- Peripheral T Cell Lymphoma Biobank
- Mantle Cell Lymphoma Biobank.
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