March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...
January 28, 2021
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a..
December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..
November 23, 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all..
October 28, 2020
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO..
September 14, 2020
“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to..
July 28, 2020
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was..
June 29, 2020
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either..