by Marc Ellison | Sep 29, 2022 | Regulatory Submission, SEND, Sensible 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...
by Marc Ellison | Sep 14, 2022 | Regulatory Submission, SEND, Sensible 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...
by Marc Ellison | Aug 31, 2022 | Regulatory Submission, SEND, Sensible SEND
The CDISC SEND team have several new standards edging their way towards publication. The SENDIG-Genetox is the CDISC SEND standard for the representation of in vivo genetic toxicology studies. This has completed an internal CDISC review and should soon be...
by Marc Ellison | Aug 17, 2022 | Regulatory Submission, SEND, Sensible SEND
This week I’ve been thinking about some of the verbiage that we use to describe how we work with SEND. I’m worried that sometimes this may be misleading, misused or misunderstood. An obvious example that springs to my mind is the use of the word ‘dataset’. The correct...
by Marc Ellison | Aug 3, 2022 | Regulatory Submission, SEND, Sensible SEND
How do you create a standardized model for data that drastically vary from lab to lab? Of course, I’m talking about clinical signs. When the clinical signs domain (CL) was first defined in SEND, it was clear to the modellers that every lab collects and reports...
