by Marc Ellison | Feb 17, 2021 | Regulatory Submission, SEND, Sensible SEND
Beyond /bɪˈjɒnd/ Preposition “more extensive or extreme than; further-reaching than.” This week I have been writing the abstract for my talk at this year’s SOT meeting. Even though the event is again virtual, as you may have guessed by now, I’ll take any...
by Marc Ellison | Feb 3, 2021 | Regulatory Submission, SEND, Sensible SEND
In the last CDISC SEND Core Team meeting, we got to discussing Anti-Drug Antibody (ADA) data, and its representation in SEND. We were debating what we’d recommend, and this is the cause of my conflict. The purist within me wants to scream “Custom Domain!”. The...
by Marc Ellison | Jan 20, 2021 | Regulatory Submission, SEND, Sensible SEND
“SEND is just an electronic representation of your study report.” This used to be my stock phrase. I actually believed it. It was how the world seemed a few years ago. I meant every word of it. The concept is admirable, but the reality seems to be getting more removed...
by Marc Ellison | Jan 6, 2021 | Regulatory Submission, SEND, Sensible SEND
Well Happy New Year one and all! After saying a final sayonara to 2020, I’m sure that you, like me and the rest of the world are hoping that 2021 ends up being so much better than its predecessor. That’s got me thinking about what’s happening with SEND in 2021. As...
by Marc Ellison | Dec 16, 2020 | Regulatory Submission, SEND, Sensible SEND
This month marks the anniversary of the start of the requirement for SEND. It has been 3 years since SEND became required for INDs and 4 years since it’s requirement for NDAs. In our world, that really is not a long time. Yet, for many of us, SEND has completely...
