We at Mivigilance ensure that GCP audits will put a strong emphasis on the reliability of the performance-related processes. GCP quality checks must be rigorous, however it is challenging to perform in an ever-evolving world, full of uncertainties. Auditors at Mivigilance are skilled and devoted to handling difficulties in every aspect, including physically accessing the investigator sites and doing the necessary audit remotely, in other words, taking a rightsized approach to the current circumstances. In accordance with the ICH-GCP E6 (R3) guideline, we provide a broad range of services in good clinical practices. Our range of GCP services include:

• Investigator Site Audits – Phase 1 to 4, Routine, Targeted, For cause
• Systems Audits – Sponsors, CRO, BA/BE, ARO, Operations
• Mock Inspections Audits– Investigator site, Sponsor, CRO, Facilitation
• Data Management Audits – Database Audits, DMS
• Trial Master File (TMF) Audits
• Document Audits – CSR, Data reviews, IND/NDAVendor Audits