Robust Quality Assurance is essential to ensure that clinical trials are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and sponsor expectations. CRS provides independent and systematic Quality Assurance services to support data integrity, subject safety, and inspection readiness throughout the study lifecycle.

Our Quality Assurance activities focus on the evaluation of processes, documentation, and systems used in clinical trial conduct. We perform risk-based audits of clinical sites, vendors, and internal processes to verify compliance with applicable regulations, study protocols, and standard operating procedures. Audit scopes are tailored to study phase, complexity, and risk profile.

CRS supports sponsors in identifying compliance gaps and implementing effective corrective and preventive actions (CAPAs). We work closely with clinical operations, regulatory affairs, pharmacovigilance, and project management teams to ensure that quality findings are addressed in a timely and sustainable manner. Clear documentation and follow-up processes support continuous improvement.

In preparation for regulatory inspections, CRS provides readiness assessments, mock inspections, and inspection support. We assist in the review and organization of trial master files, essential documents, and quality systems to ensure transparency and traceability. Our team supports sponsors during inspections and regulatory interactions as needed.

By applying an independent, structured, and pragmatic approach, CRS Quality Assurance services help minimize compliance risk, strengthen quality systems, and support the successful and defensible conduct of clinical trials.