Agatha Clinical is a ready-to-use application for creating, managing, and tracking Trial Master File (TMF) documents and processes.

Agatha Clinical connects sponsors, CRO staff and site resources to simplify the creation and tracking of essential TMF documents. It is cloud-based and available immediately — no extended planning and start-up project, Key capabilities include:
Automatically create studies and site document placeholders based on the 3.1 TMF reference model.

  • Create every essential document type from templates and forms
  • Route items through review and approval workflows
  • Track “what’s missing” to ensure inspection readiness
  • Meet 21 CFR Part 11 requirements, including e-signature requirements
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