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 …

A week of working on 3 separate Implementation Guides

This is the week of the CDISC Spring SEND Virtual Face-to-Face meeting, and yes that’s still an oxymoron, but hopefully this will be the final time as future Face-to-Face meetings are planned to back in person again. While tee week mainly focuses CDISC volunteers on progressing the standard, one of the highlights of the event …

What’s the deal with the FDA Feedback Letters?

This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko. I asked him for his opinions on the FDA feedback letters that sponsors receive after IND submissions. Specifically, his thoughts on their importance and impact – Here’s what he had to say: Whenever a sponsor receives a letter or feedback from …