4 reasons to use entimo’s Define.xml Generator:
1. Rapid creation without programming
Reusable metadata templates and comfortable GUI allow rapid creation
without programming a single line of code.
Central repository maintains up-to-date information
including templates accessible to all users.
Controlled links between versioned elements provide for error-free
Universal approach for SDTM/ADaM define
Metadata driven concept allows to create define for SDTM, ADaM and
even custom structures.
Entimo’s Integrated Clinical Environment (entimICE), a dedicated generator
allows Define.xml for SDTM, ADaM and other datasets to be created with several mouse clicks from metadata
Only four steps are required:
1. Use Metadata Templates
Entimo provides you with a set of standard SDTM domains saving your
precious time. The templates can be used as they are or adjusted to
customer specific models (SDTM+). Domain level metadata is already
preconfigured for standard SDTM domain definitions.
2. Define Data Elements
You can comfortably create and maintain additional data elements
such as value level metadata and algorithms using powerful data grid
with filtering and query definition dialog. All information is
stored in the central repository and is subject to full-fledge
traceability, version control and workflow. If available, you can
load datasets with the required information by using dedicated file
and database wizards.
3. Define Dependencies and Links
Drag-and-drop GUI allows you to define necessary links between the
metadata and all required data elements. A highlight of the tool is
the aCRF page extractor which automatically scans aCRF for page
numbers where domain attributes are referenced and stores them in
4. Create Define.xml
As the last step, you need only to select domains to be included–
Define.xml is automatically created in a specified location.
Controlled terminology and other data elements are included into Define.xml on the fly and are up-to-date with consistent links.
If some data
elements have changed, you just need to press the button again to
create up-to-date Define.xml.
Easy as this - no programming, few
mouse clicks away!
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Generator is part of
fully GCP and 21 CFR Part 11 compliant, modular and controlled e-clinical solution
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