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 …

Everyone is talking about it, but is anyone doing it?

It’s the thing that immediately springs to mind when we first learn that SEND and SDTM are so closely related. The idea that there may be shared databases and tools, and most importantly, the nonclinical data and clinical data could be compared. I’m guessing that anyone reading this blog will know that SEND is the …

Thinking about the challenges facing today’s SEND newbie

I started Sensible SEND thinking back to 2012 and my initial impressions & experiences of SEND. You can read that early post here, but as a fish-out-of-water I really struggled and was completely disoriented by this new world I’d landed in. I remember thinking to myself “These people speak a different language! What’s a Tee-Pee …

So, what did we learn from the FDA’s DART Fit For Use Pilot?

For most organizations, the FDA’s SENDIG-DART v1.1 Fit-For-Use (FFU) pilot started with the Federal Register notice being posted back in October 2020. For some of us it began earlier when it became apparent that the FDA had an appetite to adopt the SEND standard for Developmental and Reproductive Toxicology (DART). That meant a pilot was …