KYAMCH-BRS has an independent Quality Assurance team provides valuable input into improving internal processes and ensuring compliance with regulatory requirements, protocol adherence, and global standard operating procedures, promoting research subject safety and data integrity. Providing insight into clinical practice at all phases of study
Our expert team help you in:
- Internal system audits
- Trial Master File (TMF) audits
- Vendor qualification audits
- Investigative site audits
- Regulatory document audits
- Database audits
- Computer system validation audits
- Staff training
- GSOP reviews and system oversight
- Hosting sponsor audits
- Management of a Corrective and Preventive Action (CAPA) program
KYAMCH-BRS CAN ALSO PROVIDE THE FOLLOWING AUDITING SERVICES FOR SPONSORS:
- Trial Master File (TMF) audits
- Vendor qualification audits
- Investigative site audits
- Database audits
- Computer system validation audits
- Site preparation for regulatory inspection
