Clinical Services Quality Assurance

Quality is a constant goal and at the core of our philosophy. Charles River’s global clinical Quality Assurance (QA) staff combines expertise with knowledge of FDA, ICH-GCP, and local requirements and regulations including the European Clinical Trials and the GMP Directives.  Clinical QA assures that Charles River’s obligations to its customers, the regulatory authorities, and its internal quality systems are met through a program of planned and unscheduled quality audits.

Contract QA Services

In addition to our internal quality assurance program, our team offers an array of contract QA services for all stages and elements of clinical trials including:

• Investigator site audits
• Independent database audits
• Trial master file audits
• Vendor audits/assessments
• Clinical study report and integrated report audits
• Audits of pharmacovigilance activities
• Computer systems validation audits/advice
• Regulatory inspection preparation visits
• Laboratory audits
• Audit pharmcoakinetic data analysis and reporting
• Standard Operating Procedures (SOP) writing
• Training on a wide range of quality and regulatory issues
• Compliance advice and consultancy

Please check out further information on Regulatory Affairs and Quality Programs within the Charles River Corporation.

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