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As of today, our Industry has not defined any approach, nor does an official regulatory agency..

In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...

The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a..

Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..

The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all..

About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO..

“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to..

CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was..

From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either..