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The Quality Assurance Unit (QAU) operates independently, of the various departments involved in the conduct and monitoring of clinical and bioanalytical studies conducted at Semler Research Center. Our QA system ensures adherence to International and National Regulatory Standards and guidelines.
The primary QA activities are:
- Facility/System Audits
- Protocol/CRF inspections
- In-process Audits
- Data and Report Audits
- Audit facilitation and feedback
- Co-ordination of global external audits by clients or regulatory bodies
- SOP Management
- Monitoring Validation activities
- Archive Management
We also offer the services of our strong Quality Assurance Unit for monitoring or auditing studies being conducted by other CROs or pharmaceutical units. |