by Marc Ellison | Jul 20, 2022 | Regulatory Submission, SEND, Sensible SEND
Since the FDA publicly presented clarification on the scope of SEND back in October 2020, the topic has been continually discussed and queried. The Technical Conformance Guide (TCG) was updated in September 2021 to give yet more detail and address specific areas that...
by Marc Ellison | Jul 6, 2022 | Regulatory Submission, SEND, Sensible SEND
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...
by Marc Ellison | Jun 22, 2022 | Regulatory Submission, SEND, Sensible SEND
I started Sensible SEND thinking back to 2012 and my initial impressions & experiences of SEND. You can read that early post, 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...
by Marc Ellison | Jun 8, 2022 | Regulatory Submission, SEND, Sensible SEND
For this week’s blog post, I thought it would be good to discuss the current use of the define.xml file within the nonclinical industry, so I’ve asked Charuta Bapat to discuss this with us as her enthusiasm for the Define-XML is bordering on infectious. Charuta works...
by Marc Ellison | May 25, 2022 | Regulatory Submission, SEND, Sensible SEND
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...
