Define-XML services portfolio


Training | Define-XML v2.0 for SDTM

Aimed at both programmers and non-programmers such as data managers or statisticians, this single day training provides an understanding of how to collect, compile, complete, and validate the data and metadata required for the creation of Define-XML for SDTM. It briefly touches on the technology behind XML and tools available to produce the file. Prior knowledge of XML or programming is not required.

This training can be provided either on- or off-site and can be tailored to your specific needs.


Outsourcing | Let us create and validate Define-XML for you

Let our experts do the work for you! Provide us with the documentation of your clinical trial and share your existing metadata with us. We’ll create, validate, and deliver a fully compliant Define-XML for you, to include in your submission without further hassle.


Consulting | Get support doing it yourself

You want to produce Define-XML yourself, but you could use some support? Or you’ve created your Define-XML and are looking for a second opinion? We’re happy to make one of our CDISC experts available to help you out. Whether you’re pondering about the best approach to take, or can’t wrap your head around value level metadata, we’ll provide the support that you need.


Please feel free to contact Melanie Schopp or Jules van der Zalm for further information and pricing.