PharmaAudit was asked to perform a Sponsor Trial Master File Audit for a Pharma Company.

Initial preparation was conducted away from site and this involved reviewing the protocol, SOPs and other associated documentation.

A 2 day visit to the Sponsor's Offices where the Trial Master enabled our Auditor to go through the Trial Master File to conduct the audit.

After the review the Auditor met with the Sponsor Team to provide initial feedback prior to writing the Audit Report and making suggestions for general improvements.

Once all corrective actions had been taken an audit certificate was issued.