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ODM Study Composer - Highlights

  • Replaces MS Word and Excel and accelerates the CRF and DVP set-up process
  • Automatically generates the eCRF design, annotated CRF, data validation plan, visit matrix, database specs and other key documents from a single, central XML-based set of metadata, keeping everything in sync.
  • Builds an item and CRF library for consistent re-use of existing items and CRF definitions in standard CDISC ODM format
  • Enables unambiguous communication and efficient collaboration between CROs, sponsors, vendors and all other parties involved