by Marc Ellison | Dec 7, 2022 | Regulatory Submission, SEND, Sensible SEND
There have been rumors of a proposed Nervous System domain (NV) for many years, yet still nothing has been published and it’s not listed in the content for SEND 4.0. So, just what is going on? At the recent joint FDA and CDISC SEND meeting, the full scope of SEND 4.0...
by Marc Ellison | Nov 23, 2022 | Regulatory Submission, SEND, Sensible SEND
It was going to be called SEND 3.2 but now it’s going to be called SEND 4.0. Why the change and does it really matter? As you may have guessed, the change is due to the scope of the updates. The addition of several new domains and data types mean this is seen as a...
by Marc Ellison | Nov 9, 2022 | Regulatory Submission, SEND, Sensible SEND
There’s an argument I occasionally hear that absolutely infuriates me. It’s usually some variation on the line, “The FDA doesn’t care about the quality of SEND, so why should I?” I know I’m paraphrasing, and probably stating this a little too bluntly, but it’s based...
by Marc Ellison | Oct 26, 2022 | Regulatory Submission, SEND, Sensible SEND
Last week was the Fall 2022 CDISC meeting. As usual, the highlight of the meeting was the public joint presentation between CDISC and FDA. With each event, cross study analysis has slowly become more of a focus. This time, there were multiple presentations referring...
by Marc Ellison | Oct 12, 2022 | Regulatory Submission, SEND, Sensible SEND
“If you want to go fast, go alone but if you want to go far then go together.” Proverb I don’t like moving slowly. I like to feel that things are moving quickly, and the end is in sight. I can become frustrated when things do not move quick enough. Yet, I continually...
