CDISC end-to-end

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 ...

This is my personal opinion. It is not the opinion of CDISC, not the opinion of any of the CDISC development teams I belong or do not belon...

Two friendly colleagues from pharma companies pointed me to very recent FDA publications about LOINC , the worldwide coding system for labor...

The FDA very recently published a report on their pilot of the use of Dataset-XML as an alternative to SAS-XPT (SAS Transport 5) for SDTM, ...

Define.xml is a CDISC standard , based on XML, allowing sponsors to provide metadata for SDTM, ADaM and SEND electronic submissions to the F...

In a recent discussion with an important CDISC representative (well, they are all important), I heard the remark that the therapeutic area u...

Yesterday, one of my smaller dreams came true. Some years ago, when I started working with electronic health records (EHRs), I discovered ...

I now also implemented these services into the "Smart Dataset-XML Viewer". I still need to QC it and will then make the new versio...