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.