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Study Composer


XClinical’s STUDY COMPOSER provides an intuitive graphical user interface for study setup including eCRF design and data validation plan. As a replacement for MS Word and Excel during the preparation of a clinical trial, STUDY COMPOSER saves considerable time and cost.

Not just an eCRF builder – While building eCRFs using the drag-n-drop user interface, Study Composer is automatically generating the following:

  • Annotated CRFs
  • Data validation plan
  • Visit matrix
  • Codelists
  • XML-based set of metadata

This ensures that all necessary documents are automatically consistent with each other, thereby eliminating the manual transcription effort required to maintain different documents and increasing quality by avoiding inherent error risks.

Data managers can utilize the STUDY COMPOSER to build and use an item and CRF library, which enables them to effectively and consistently re-use existing items and CRF definitions. In this way, the tool automatically ensures compliance with the international CDISC ODM standard format, enabling the CRF and database design to be exchanged with different systems and organizations, e.g. between sponsors and CROs.

Key advantages:

  • Intuitive graphical interface utilizing drag and drop or copy/paste functionalities for quick and easy CRF design
  • Easy and unambiguous definition of a data validation plan
  • Automatic output of the annotated CRF, visit matrix and data validation plan in table form or on a customizable style sheet
  • Automatic output of source XML
  • Automatic version control and management of amendments
  • Validated, CDISC ODM-compliant storage of the CRF design
  • Smart search & copy functions for creating and using a library
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