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The CDISC Define.xml Checker

Upon request of many of our customers, who are frustrated about the Define-XML validation tools that are currently available, and especially the one used by some regulatory authorities, we developed our own Define-XML validation tool, this time implementing rules developed by the CDISC Define-XML Team (and not by programmers that have never been involved in the development of the standard), and based on the CDISC XML Schema Validation for Define.xml White Paper and Schematron technology

As one of the developers of the Define-XML standard, and as a CDISC Authorized Define-XML Instructor, we know every detail of the Define-XML standard extremely well, and thus are the first choice for a Define-XML validation tool.

The Define.xml is not a free tool, but for that, you get real quality, unlike other tools that are free, but mix up the rules for define.xml v.1.0 and v.2.0, and generate many false-positive errors.

Instead, the Define.xml Checker provides:

The Define.xml Checker is used by a many sponsor organizations (big pharma, biotechnolgy companies), CROs, and all major service providers specializing in generation of SDTM-compliant submissions and legacy data conversion.

The CDISC Define.xml Checker


Single license (perpetual license, PC or server): US$ 1,200 / 1,000

Free downloads are available for non-profit users: academia, state regulatory organizations, regulatory reviewers

How to order?

The best and easiest way to order is using a purchase order from your organization

Contact XML4Pharma
XML4Pharma, Katzelbachweg 18, A-8052 Thal, Austria