Auditing

• Investigator site audits

Overall review of Investigator’s site to assure compliance with ICH GCP requirements and appropriate regulations before, during or after a specific clinical trial.

• Assessment audits of vendors (CROs, local laboratories, warehouses, data management units, couriers)

Independent audits of vendors prior to contract placement to give assurance that the organization is fully compliant with GCP, GMP, regulatory requirements and able to provide the service required.

• System audits

Audit of systems and processes to identify potential risks for the trial and to provide recommendations for improvement.

Our auditing deliverables include:

• Audit Plan
• Graded Findings Audit Report
• Recommendations for Improvement and Achieving Compliance
• Audit Certificate

Our company also offers a wide range of different audits:

• Document audit (clinical study protocol, informed consent, clinical study report, investigator brochure, safety summary, etc)
• Trial Master File audit
• Database audit
• For-cause audit

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