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TMF Inspection Readiness Solutions: Workshops

Inspection Readiness & Support

Strategy and planning around inspection readiness can often be challenging to balance with the many considerations during study execution. Our TMF Inspection Readiness Workshops provide you with the tactical guidance necessary to successfully navigate regulatory inspections. Our team has proven experience with FDA, EMA, MHRA, PDMA, and others, resulting in approvals.

  • Inspection Readiness and Preparation Workshops
  • Needs Assessment Workshop
  • Sponsor Oversight Requirements Workshop
  • eTMF Requirements Workshop
  • Inspection Support
Mapping: TMF Reference Model & Index Configuration

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.

Configuration & Requirements

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.

Policy, SOP & Process Reviews

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.

Change Management Planning

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:

  1. Your organization’s goals
  2. The appetite for change among stakeholders
  3. The involvement of different departments, companies, and stakeholders
  4. The TMF expertise within existing leadership and study team personnel
  5. The specific requirements of your organization and your upcoming and/or ongoing clinical trials. Sponsors and CROs around the world have worked with our experts to adapt to new TMF paradigms to improve their overall inspection-readiness.
Regulatory Compliance

Our teams are always up to date on the latest regulations that impact study conduct and expectations and requirements for TMF documentation. This includes items such as:

  • 21 CFR Part 11 Regulations
  • ICH E6 R2 Guidelines
  • GCP
  • MHRA Guidance Documents
  • GPDR
  • TMF Archiving and Hosting Requirements
  • Data Destruction Requirements
  • ER/ES
  • HIPAA
  • Over 3.4 Million Documents Processed and Counting
  • 25+ Clinical Specialists Each Processing over 100 Documents Daily
  • 4,000+ Active TMFs
  • 8 Successful FDA, MHRA, and EMA Inspections
  • 22 TMFs Rescued Mid-Study
  • Managed a 1.2 Million Document TMF
  • 75% Risk Reduction
  • 10+ Years of TMF Stewardship
  • DIA TMF Reference Model Committee Members