These designated workflows comply with the World Health Organization’s Good Clinical Laboratory Practice (GCLP) guidance to meet enhanced quality and traceability standards required of assay data generated for clinical trials.
Providing a critical bridge between GLP compliance (focused on non-clinical safety studies) and GCP regulations (applying to clinical trial execution), GCLP addresses a vital aspect of clinical development: the laboratory testing of samples collected from clinical trials. It blends:
Labs providing GCLP compliant assay services must uphold stringent controls for traceability, assay precision, and data integrity to produce reliable, accurate, and auditable results from human samples that are used to make clinical decisions about diagnosis, dosing, safety, and efficacy.
At Sapient, we have validated the instrumentation, quality management system (QMS), and LIMS used in our GCLP workflows to these standards, and execute GCLP-designated studies within a robust and documented quality framework.
GCLP is applied specifically in the clinical trial context to uphold ethical standards relating to participant rights and privacy for samples collected and tested for trials.
Sapient’s GCLP compliant workflows uphold defined standards to ensure participant protection, informed consent, and confidentiality, and adhere to GCLP practices related to chain of custody, protocol adherence, standard operating procedures, traceability, and documentation, among other key aspects scoped within the guidance.
GCLP applies to laboratory work that involves analysis of human-derived samples to report results that inform the diagnosis or treatment of clinical trial participants. It covers data generated to:
It is important to note that GCLP runs in parallel with GCP – not replaces it – when a clinical trial involves testing of samples collected from human participants.
GCLP compliance is achieved through adherence to international quality frameworks like WHO’s GCLP guidance, and in the United States, is based upon a lab’s own internal assessment rather than external certification or accreditation.
Because of this, sponsors carry the primary responsibility for assuring their trial analysis is compliant with regulatory requirements for GCLP. We welcome sponsors interested in using our GCLP compliant assay services to audit our processes and procedures.
Sapient leverages our Thermo Stellar mass spectrometry platform for regulated assay work and can develop targeted assays in compliance with GCLP for any protein in our 12,000+ protein menu or through custom assay development.
These GCLP compliant assay services allow us to support clients throughout their entire drug development process. We can take biomarkers and targets uncovered in early discovery using our nontargeted multi-omics approaches and translate them into targeted single- or multiplex assays for clinical trial testing.
We can also develop bespoke targeted assays under GCLP for proteins that have already been identified as primary, secondary, or safety endpoints – even those proteins that have traditionally been difficult to measure through antibody-based methods.
The “alphabet soup” problem of GxP can muddle clarity on exactly what each framework addresses – and may lead to overfitting or underfitting compliance at a given study phase.
We define where GLP, GCP, and GCLP apply in the drug development process and provide a decision framework for selecting the right compliance level for your specific program.
Our GCLP compliant assay services are backed by deep QA and regulatory expertise within the Sapient team, comprising quality, operational, and scientific leaders who bring decades of combined experience supporting regulated studies for pharma and biotech sponsors.
Let them help you navigate clinical trial testing compliance nuances and the execution of GCLP-designated studies in line with the expectations of global regulatory authorities.
