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eTMF Solutions and TMF Services

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A practical, secure, compliant single access point for TMF documentation, supporting all essential document processes and reducing the time, costs, and risks of TMF management. Connected, fluid document collaboration and learning management system solutions ensure a complete approach to clinical documentation and compliance.

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TMF Services

Comprehensive TMF management services help study teams process TMF documentation, establish best practices, and stay inspection-ready. Scale your study team anytime, anywhere around the world, with on-demand TMF document specialists, quality professionals, and clinical experts.

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A mobile eTMF that enables site document capture and key eClinical workstreams anytime, anywhere—saving CRAs and investigative site personnel weeks of time processing documents.

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eISF and Site Portal

An investigator site file solution that reduces administration and improves speed and compliance for site personnel and study teams with digital investigative site binder processes.

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eTMF | TMF Features: Achieve real-time inspection readiness starting from the creation of a document

  • Millions of Documents Processed and Counting

  • Successful FDA, EMA, MHRA, PMDA, and GCP Inspections

  • 40+ TMFs Rescued Mid-Study

  • Managed Single TMFs with over a Million Documents

  • Over 75% Risk Reduction

  • Thousands of Active TMF/eTMFs

  • TMF Reference Model Committee Members and Influencers

  • 12 Years of TMF Leadership