Audit of investigative site operations to determine adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations. Our team has expertise in auditing multiple sites and BA/BE facilities across India.

Audit of Institutional Review Board operations and documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR 50 and 56).

Trial Master File Audits – Comprehensive review of essential documents according to ICH GCP, and client SOPs.

Phase 1 Unit Audits – Review of facilities, equipment, procedures and personnel, either pre-study or during study conduct.

CRO and Clinical Laboratory Audits – Pre-contractual audits, evaluation as preferred service providers or audits involving ongoing projects.

Database Audits – Audit of a sample of data from a locked database according to either the client or Vaatsalya Clinical SOPs. Clinical Report Audits – Audits of clinical reports against client SOPs and ICH GCP requirements.