KABRS 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 Quality Assurance team internally supports:

• 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.

KYABRS can also provide the following auditing services for sponsors:

• Trial Master File (TMF) audits.
• Vendor qualification audits.
• Investigative site audits.
• Database auditss.
• Computer system validation auditss.
• Site preparation for regulatory inspection.