Quality Assurance
KLINTRA Quality Assurance team operates independently and reports directly to the management. Our QA team is unique because of its training & experience in ensuring International standards and ethics. Klintra's Quality Assurance offers in-house and independent Quality Assurance audits. Following each Clinical Quality Assurance audit, comprehensive and confidential reports and audit certificates are produced according to KLINTRA consulting standard operating procedures or client specifications.
Clinical Quality Assurance audits encompass all aspects of the clinical development process that includes:
• IRB Audits
• GCP/GLP audits
• Trial Master File Audits
• Investigator Site Audits
• Phase 1 Units
• Central Laboratory Audits
• Clinical Trial Supply Audits
• Computer Systems Validation Audits
• Database Audits
• Sponsor Audits
• System Audits
• QMS Gap Analysis
• Adverse Event Reporting System Audits
• Pharmacovigilance Audits
• Biometrics Systems Audits
• Clinical Study Report Audits
• In house files' audit
• Standard Operating Procedure (SOP) Evaluations
• 21 CFR Part 11 Compliance Audits
• Vendor Audits