SEND 4.0 – Just how big is this change going to be?

It was going to be called SEND 3.2 but now it’s going to be called SEND 4.0. Why the change and does it really matter? As you may have guessed, the change is due to the scope of the updates. The addition of several new domains and data types mean this is seen as a …

Virtual Control Groups and more – Update from the CDISC Fall meeting

Last week was the Fall 2022 CDISC meeting. As usual, the highlight of the meeting was the public joint presentation between CDISC and FDA. With each event, cross study analysis has slowly become more of a focus. This time, there were multiple presentations referring to this topic and the opportunity to use SEND beyond just …

SENDIG-DART is more tricky than regular SEND

I write this as I arrive at the European Teratology Society in Antwerp, Belgium to present a poster relating to the SENDIG-DART. This feels significant for a couple of reasons. Firstly, and personally, this is my first in-person conference or meeting since the COVID lockdown. To be travelling for business really feels like things are …

Reflecting on the last 10 years of SEND

Spoiler Warning: This week’s blog post is even more self-indulgent than usual. I’m recognizing two very significant anniversaries in my professional career. This month marks 25 years of working in the nonclinical space. September 1997 saw me take a programming job at a preclinical software vendor, fully in the expectation that it would be a …