Trial Master File Review

Many companies are presently evaluating how they are managing and maintaining their TMFs and considering the available options to improve their process. CCA provides a service for companies to gain an understanding of the methodology required for designing and executing effective document management and TMF maintenance.

CCA offers comprehensive pre-audit TMF reviews that ensure compliance with clients SOPs, ICH GCP and EU Directive 2001/20/EC.

As documentation and TMF issues become have more prevalent the provision and delivery of TMF Audits has become increasingly apparent and frequent. At CCA we provide a comprehensive QC and review process delivered in tandem as part of our TMF services. We provide a review or if required an audit of all essential documents in accordance with ICH GCP and EU Directive 2001/20/EC, The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005) and client SOPs. We also review the TMF assessing documentation and orientating our audit of data to support the validation effort, system security issues, and archival/backup requirements of our clients.