Inspection readiness starts with TMF readiness

Trial Master File (TMF) quality is imperative for ensuring compliance and inspection readiness. A disorganized, incomplete, or non-compliant TMF can signal deeper operational gaps to regulators, leading to inspection findings that delay approvals and compromise the integrity of clinical programs.

At G&L Scientific, we know that a proactive approach to TMF oversight strengthens inspection readiness and reinforces clinical compliance across the board. With more than 25 years of experience supporting clinical trials globally, our team helps sponsors make sure the TMF is a true asset, not a liability.

A complete and inspection-ready TMF is essential for demonstrating that a clinical trial was conducted according to Good Clinical Practice (GCP), the protocol, and applicable regulatory requirements. It also enables auditors and inspectors to assess whether key obligations were met.

Common gaps we encounter during TMF audits include:

• Missing, incomplete, or not current documentation
• Inadequate document versioning and access control
• Lack of audit trails
• Poorly documented sponsor/Contract Research Organization (CRO) communication
• Inconsistent filing practices across study teams

Any of these issues can lead to inspection findings or even cast doubt on the reliability of trial data.

As regulatory authorities increasingly emphasize TMF quality as part of their inspections, readiness for them must be proactively built into daily operations.

At G&L, we support Sponsors and CROs by:

• Conducting independent TMF audits (including eTMF systems)
• Reviewing TMF governance (SOPs, work instructions, filing plans)
• Assessing ongoing oversight and quality control activities
• eTMF system compliance assessments
• Providing remediation support when issues are found
• Preparing storyboards and narratives for potential inspection queries
• TMF closeout quality reviews

Our TMF audit and inspection readiness services are part of an integrated Product Development and Market Access Platform that connects clinical, regulatory, and quality assurance (QA) expertise under one roof.

This approach ensures that TMF health is not treated in isolation but is aligned with your operational timelines, regulatory goals, and submission plans.

Learn more about how G&L can support your TMF and inspection readiness strategy here.