Cliniserve performs audit in compliance to section 5.19 of ICH E6(R1): Guideline For Good Clinical Practice.

Audit is necessary to assess strength & weakness of CRO or hospital sites to conduct clinical study in compliance with Good Clinical Practice and applicable regulatory guidance documents. Cliniserve provides comprehensive 360 degree approach during audit and give detailed audit report to Sponsor. Findings during audits are shared as observations/recommendation to auditee to have CAPA response. We thoroughly review CAPA taken by CRO or hospital sites and based on CAPA assessment we close audit.

Our Audit Procedure Includes Audit of Following Step

  • Quality Management System
  • Site Master File
  • Comprehensive SOP review
  • Computer System Validation
  • Information technology (hardware/software environment and validations, backup systems, Part 11 compliance if applicable)
  • Quality Assurance and Quality Control Systems, policies and procedures including reporting structure and communication
  • Data Management – storage, backups, and recovery, physical environment
  • Project Management Systems, procedures and communication with sponsors
  • Interviews with department wise representatives [Clinical, Bioanalytical, Quality Assurance, Medical Writing, Pharmacokinetic & Statistical, Training, Regulatory, Information Technology] and project personnel
  • Vendors managements and audits