Good Clinical Laboratory Practice (GCLP) is a set of standards that provides direction on applying Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance to the analysis of samples from a clinical trial. GCLP compliance is a median between GLP and GCP compliance in a laboratory setting. It allows companies to have a guideline in assembling in-house facilities, instrumentation, systems and overall standard operating procedures (SOPs) that ensure laboratory studies and data results achieve the GLP and GCP compliance expectations. All areas of a clinical laboratory are included in being GCLP-Compliant, specifically, organization and employees, laboratory facilities, instrumentation, reagents and supplies, SOPs, worksheets preparation for each experiment, conduct of the experiment, data reporting, QC and QA audits, data retention, data storage, data transfer and overall confidentially.
At Champions Oncology, we want to offer the highest quality clinical data to our clients. In doing so, we know we must operate in a GCLP-compliant manner. Some of the benefits to working in a GCLP environment include:
- High quality data results that are reliable, reproducible and auditable
- The incidences of false negatives and false positives are reduced
- Results are cross-site/cross-instrument comparable to those obtained in our other GCLP compliant laboratories globally