Clinical trials depend on laboratory data for subject safety monitoring, eligibility decisions, pharmacokinetics, biomarker endpoints, and more. Yet many study labs operate in a regulatory gray space between GLP and GCP, leaving sponsors to interpret and enforce expectations across a patchwork of central, regional, specialty, and bioanalytical providers. Variability in sample handling, method validation, instrument maintenance, data transfer, or result reporting can ripple through a program—jeopardizing data credibility, delaying submissions, and increasing cost.
Good Clinical Laboratory Practice (GCLP) exists to close this gap, but implementing and sustaining GCLP across a diverse lab network is challenging. Requirements touch quality management, personnel training, environmental conditions, equipment qualification, reagents, specimen lifecycle controls, data systems, and secure electronic reporting to sponsors and CROs. Sponsors must also reconcile differing regional regulations (e.g., CLIA, CAP, ISO 15189, country-specific accreditation) with study-specific protocol demands.
We deploy experienced laboratory quality auditors—many with backgrounds in central labs, specialty/biomarker testing, bioanalytical method development, and regulatory inspection—to evaluate your lab partners against GCLP expectations, applicable regulatory frameworks, and the operational realities of your trials. Our audits surface the issues that matter most to data integrity, patient safety, and submission credibility—then map them to practical, phase-appropriate solutions.
Comprehensive GCLP compliance audits (central, regional, specialty, biomarker, bioanalytical, safety labs)
Sample accessioning, chain-of-custody, storage, and retention control reviews
Analytical method validation/verification (fit-for-purpose) assessments
Instrument/equipment qualification, calibration, and maintenance program audits
Reagent/kit control, lot-to-lot bridging, and stability documentation reviews
Quality control (QC) and proficiency testing program evaluations
Data management & LIMS/electronic data capture interface audits (data mapping, transfer integrity, audit trails)
Report generation, review, and release process assessment (including reference ranges and flagging rules)
Deviation/CAPA and change control system reviews
Staff training, competency, and ongoing qualification program reviews
Supplier/subcontractor laboratory oversight audits
Quality system & laboratory SOP gap analysis against GCLP, CLIA, CAP, ISO 15189, and sponsor requirements
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.