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..
April 27, 2020
In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC..
April 24, 2020
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)..
October 23, 2019
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance..