Ensuring Your Organization Can Maintain TMF that are Inspection-Ready at All Times
Session details:
In today’s fast-paced clinical trial landscape, regulatory inspections can occur with little notice, making it critical for organizations to maintain a Trial Master File (TMF) that is always inspection-ready. This session will explore practical strategies and proven methodologies to ensure your TMF is accurate, complete, and compliant at all times. Attendees will learn how to embed inspection-readiness into their organization’s daily operations by leveraging best practices such as real-time TMF management, risk-based quality reviews, and the use of operational metrics like key performance indicators (KPIs). The session will also cover how to foster a culture of compliance through robust training programs, stakeholder collaboration, and executive buy-in.
Key topics include:
- Developing and maintaining a comprehensive TMF plan that will outline roles, responsibilities, and quality control processes
- Implementing digital tools like eTMF systems to enhance document timeliness, completeness, and accessibility
- Conducting regular audits and risk assessments to proactively identify and address gaps in documentation
- Establishing clear oversight mechanisms for internal teams and external vendors to ensure accountability and compliance
- Preparing for inspections with mock reviews and remediation plans to address high-risk areas
