Never again struggle with the pain of turning to a mix of MS Word, Excel, and Powerpoint docs into a folder to try to customize your study startup.

With XClinical’s Composer, you can produce eCRF designs, document links, and more to live in a single intuitive interface for your team. Data managers can use Composer as the single tool to generate annotated CRFs, data validation plans, study metadata, visit matrix, database specs and all relevant documentation from a single, central XML-based set of metadata. Automatic, system-generated documents ensure accuracy and consistency, thereby eliminating the manual transcription effort required to maintain different documents.

Data managers can utilize Composer to build all elements of a study using an eCRF library. The library functionality enables the effective and consistent reuse of existing items, forms, etc., across different studies.

The tool automatically ensures compliance with the international CDISC ODM standard format, enabling the eCRF and database design to be exchanged within different systems and organizations (for example between sponsors and CROs).

Customers using an EDC system that can import CDISC ODM metadata as Composer supports the automatic setup of an EDC database. With an EDC system that does not have this capability, Composer still provides the best possible, unambiguous eCRF specifications, including an underlying database and data validation plan. This guarantees the most efficient communication between different teams and organizations.

Composer highlights

  • Any edit checks, including cross-page and cross-visit edit checks, can be designed in a graphical point-and-click / drag-and-drop manner-> no programming knowledge is required.
  • Library functionality enables the user to copy and paste everything from single questions to entire case books for reuse in another study.
  • Study amendments are easily implemented without any database programming. Composer automatically implements the CDISC version control mechanism.

Key features are:

  • Intuitive graphical user interface for quick and easy study setup
  • Smart search & copy functionality to create and use a library
  • Rule and formula editor enables the easy and unambiguous definition of a comprehensive data validation plan without the necessity of programming knowledge
  • Automatic output of the annotated CRF, visit matrix and data validation plan
  • Easy setup and management of amendments
  • Validated CDISC ODM-compliant storage and export of the CRF design
  • Can be used in combination with any EDC system
  • Operates offline (MS Window, Linux, MacOS) and online (any browser)