CDISC end-to-end

In my previous post , I presented our new " Define.xml Designer " software, implementing all "best practices for generating d...

A few of us are already making thoughts about what should be the requirements for a CDISC ODM 2.0 standard. Especially integration with heal...

Although my posting " Creating define.xml - best and worst practices " is the most read blog entry of my blog site, people seem no...

As promised on LinkedIn , I analyzed the results of the survey where people were asked the question "In my opinion, the FDA should ......

Yesterday, I accomplished something that I believed was difficult, but after all wasn't: to develop the FDA and PMDA MedDRA validation r...

The newest publication of the FDA about " Use of Electronic HealthRecord Data in Clinical Investigations " triggered me to pick up...

This weekend, after returning from the European CDISC Interchange (where I gave a presentation titled " Less is more - A Visionary View...

During the last days, I could again make considerable progress in writing FDA and CDISC SDTM and ADaM validation rules in the vendor-neutr...

Today, I attended an excellent "CDISC members only Webinar" given by Phil Pochon (Covance) on LOINC and it's use in CDISC. Phi...

This morning and the last week was frustrating in one aspect. I had to retrieve some personal information from the Austrian tax portal ...