CDISC end-to-end

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...

Today, I added three more web services, which have to do with SDTM value lists: Validate whether a CDISC unit is a correct unit for a giv...

In the last weeks and months, with help of my students at the university , I developed some more web services for use with CDISC standards, ...

In CDISC SDTM , values for non-standard variables (i.e. sponsor-defined variables) need to be submitted in separate data sets, the so-called...

Last week, I worked on a mapping between the CDISC-CT [UNIT] codelist , and UCUM . For every "unit" published by CDISC (there are ...