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Among the clinical QA audits which we conduct are:
Our Quality Assurance group reports directly to KCR’s President and is managed by a QA leadership team composed of QA leaders in Clinical Research.
Our Quality Assurance team has the medical, technical and regulatory expertise to ensure that standards, processes and personnel are in place to achieve consistent and effective performance across all KCR locations and investigational sites. The QC team works closely with all operational personnel to share information, leverage experience and create consistent practices across all our offices.
Our QA team not only assures that KCR has a comprehensive internal quality assurance program in place, but also provides audit services to our clients as part of a full-service contract or a standalone project.
Among the clinical QA audits which we conduct are:
- Project Quality Management planning and implementation
- Clinical investigator site audits. We provide routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews
- Clinical study document review
- Post audit support: Corrective and Preventive Action plans and process improvement implementation
- Our QA team also provides staff training in GCP, FDA and ICH regulations on audit and inspection preparation