Inspection Readiness Services

Maintaining a complete, organized, and compliant Trial Master File (TMF) is essential for the success of any clinical trial. TMF Quality Review services are designed to ensure that the TMF meets regulatory requirements, adheres to Good Clinical Practice (GCP) standards, and is inspection-ready throughout the trial lifecycle. 

Key Features of TMF Quality Review Services: 

• Document Completeness and Accuracy: Comprehensive review to confirm all essential documents are present, accurate, and properly filed.
• Regulatory Compliance: Verification of adherence to ICH GCP guidelines and applicable regulatory standards, such as those set by FDA and EMA, to mitigate compliance risks.
• Inspection Readiness: Assessment of TMF structure and organization to ensure it is accessible and ready for regulatory inspections.
• Version Control and Metadata Review: Ensures all documents have correct version histories and accurate metadata, supporting clarity and traceability.
• Timely Filing: Evaluation of document filing timelines to confirm alignment with the trial's progress and regulatory expectations.
• Risk Identification and CAPA Recommendations: Identification of gaps, risks, or inconsistencies with actionable solutions through corrective and preventive actions (CAPAs).

Our TMF Quality Review services provide sponsors and CROs with peace of mind by ensuring the Trial Master File accurately reflects trial conduct and compliance. Whether performed at the trial start-up, interim, or close-out phase, a thorough TMF review strengthens regulatory adherence, data integrity, and inspection readiness. 

Inspection readiness should be built into all processes during the clinical development of a product. With good planning upfront at the beginning of the program, many of the issues found during an inspection can be either prevented or their impact lessened.

Inspection readiness strategic planning can be incorporated in the following areas: 

• Standard Operating Procedures
• CRO and Vendor selection, management and oversight
• Investigator selection and management
• Clinical site management
• Monitoring procedures and activities
• Evaluation and reporting of adverse events and serious adverse events
• IMP accountability and documentation
• Trial Master File (TMF) oversight
• Regulatory documentation