CDISC Presentations and Publications
As one of the main evangelists of the CDISC standards in Europe, Jozef Aerts of XML4Pharma has given a good amount of presentations on this topic.
Also, we have written a number of articles on the use of CDISC standards which have been published in high-quality magazines.
Presentations
- "From Protocol to Submission. The Value of using CDISC Standards. Experiences from a long-time implementer".
The Changing World of Clinical Trials - European Clinical Research Conference, European eClinical Conference, 16th Annual European CDM Conference, Basel, November 2006.
- X.Bessette (i-Clinics) and J.Aerts: "Implementing CDISC LAB, ODM and SDTM in a Clinical Data Capture and Management System - How we did it".
CDISC 2006 European Interchange Conference, Berlin, April 2006.
- "Tools for working with CDISC ODM, Lab and define.xml Standards – What is available ?". CDISC 2006 European Interchange Conference, Paris, April 2005
- "Implementing the CDISC ODM standard", PSDM Workshop on CDISC, Weesp, June 2003
Publications
- "Submitting clinical data to the FDA in XML format". Regulatory Rapporteur, Vol.2, No.6, June 2005
- "CDISC Set the Standard". European Pharmaceutical Contractor, Winter 2005
- "CDISC Standards Energize EDC", Applied Clinical Trials, October 2006 (available online)
XML4Pharma, Schlossbergstr. 20, 78224 Singen, Germany. Phone: +49 7731 975044
