TMF lifecycle optimization workshops will help you streamline the management of your TMF at every stage of the clinical trial. Your team will then have the opportunity to adopt best practices, helping the TMF to remain complete, compliant, and inspection-ready.

• Document creation and version control
• Best practices for submitting records
• Ongoing quality control
• Indexing and filing best practices
• Final archiving and long-term storage

Get a strategic crash course on how to set up your TMF to map documents to their compliant destinations in the index based on the TMF Reference Model or your study-specific index requirements. We will help ensure your process is seamless.

• Align documents with TMF Reference Model standards
• Customize indexing based on study-specific needs
• Streamline document classification for efficiency
• Establish a structured, compliant TMF framework
• Ensure consistency across studies and regulatory inspections

TMF inspection readiness is a continuous, proactive process. Our workshops assist your study team with critical regulatory activities, from pre-inspection preparation to post-inspection follow-up.

• Pre-inspection gap analysis
• Setting up a culture of inspection readiness
• Critical documents and risk assessment
• Real-time document retrieval
• Effective inspector interactions and simulations
• Post-inspection follow-up

Apply in-depth key regulatory frameworks and compliance to your TMF to stay inspection-ready on a global scale. We guide you through FDA 21 CFR Part 11, ICH E6(R3) GCP, MHRA GxP, TGA GCP, PMDA GCP, HIPAA, GDPR, EMA Annex 11—including requirements for:

• Data destruction
• Electronic records and signatures
• MHRA guidance documents
• TMF archiving and hosting
• Regional compliance across multiple sites

Sponsors and CROs around the world have worked with our experts to adapt to new TMF paradigms to improve their overall inspection-readiness. Whether you’re new to managing a trial master file or upgrading to a new eTMF, our expert TMF team will evaluate and help you develop plans based on:

• Your organization’s goals
• The appetite for change among stakeholders
• The involvement of different departments, companies, and stakeholders
• The TMF expertise within existing leadership and study team personnel
• The specific requirements of your organization and your clinical trials

Get help with your eTMF configuration and requirements from the team that helped bring eTMF to the mainstream. With thousands of eTMFs implemented over 10+ years, you can ensure comprehensive and risk-controlled guidance on your organization and study-specific eTMF needs.

• Metadata, taxonomy, and indexing
• Audit trail and security framework
• User roles, permissions, and workflow
• Custom requirements assessment

As organizations adopt eTMF technology and more robust TMF processes, best practices must also evolve. Teams new to eTMF or limited on resources get help from our TMF experts to develop these procedural documents and processes to ensure they are meeting global regulatory requirements.

• Assess existing TMF policies and SOPs for compliance
• Identify gaps in eTMF process alignment with regulations
• Develop and refine procedural documentation
• Implement best practices for eTMF governance
• Support teams in regulatory inspections and compliance reviews