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XML4Pharma and CDISC implementation services

Implementation Services

XML4Pharma is a CDISC Registered Solutions Provider

As an early adaptor of the CDISC standards, XML4Pharma has gained a large amount of experience in implementing the CDISC standards (ODM, Lab, define.xml, SDTM) at technology vendors, CROs and pharma companies, both in Europe and the US.

We help large sponsor companies with the implementation of CDISC standards, usually on basis of consultancy. This goes from providing tailored courses and trainings, to project-based consultancy (for example helping them to choose the right technologies), and up to development of software and systems.

Furthermore, we help sponsor companies and CROs with conversion of legacy data to CDISC standards.

Very regularly, we are helping CROs learning them how to retrieve clinical data from their databases in XML format (Oracle, SQLServer, Access, ...) or CDMS, and to transform these data into the CDISC ODM and/or Lab format.

For a number of EDC vendors, we developed and provided the necessary software to allow their systems to import and export data in CDISC format (ODM, Lab), and for enabling their systems to become CDISC-compliant.
If your EDC system has the ability to import and export data in CDISC format, XML4Pharma may have implemented that !

As a very early adaptor of the CDISC Lab standard, we developed a system to validate CDISC Lab files against the standard. This system is now freely usable on our demo application server. An extended version of this system was developed for a CRO based in Northern America, for handling all incoming CDISC Lab files.
This system is now used by several major Central Laboratories.

Knowledge and Technology Transfer

We find knowledge and technology transfer important. We are not one of these consultants or technology providers that provide you with a black-box solution.
At the contrary, during an assignment, we learn your people understanding the CDISC standards and how to work with them.
When developing a software solution for your company, we provide the source code of that software together with the full software documentation.

Our technologies

XML is a rather young (<10 years), but well established technology (or better: set of technologies) that is still evolving fast. XML4Pharma constantly follows the developments in the XML world, and constantly acquires new skills to work with these technologies.

A (non-complete) list of technologies we use (and are very good in) for the development of solutions for working with CDISC standards is:

Software deliverables

In case we work for a customer on a software project, the customer obtains:

XML4Pharma is a CDISC Registered Solutions Provider

Contact XML4Pharma
XML4Pharma, Katzelbachweg 18, 8052 Thal, Austria