Good Clinical Practice (GCP) Laboratories
The University of Liverpool has two Good Clinical Practice (GCP) Laboratories: the Bioanalytical Facility (BAF); and the GCP Laboratory Facility (GCPLab).
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.
GCP Laboratory Facility (GCPLab)
Academic lead Professor Bill Greenhalf; Lab Manager Dr Mel Oates
GCPLab conducts sample 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 Royal Liverpool Hospital Clinical Research Facility, Clatterbridge Cancer Centre (CCC) and pharmaceutical companies such as Janssen.
Biobanks managed through the GCPLab include: