by Marc Ellison | Dec 1, 2021 | Regulatory Submission, SEND, Sensible SEND
As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies...
by Marc Ellison | Nov 10, 2021 | Regulatory Submission, SEND, Sensible SEND
This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the...
by Marc Ellison | Oct 27, 2021 | Regulatory Submission, SEND, Sensible SEND
As you are probably aware, Instem recently acquired PDS Life Sciences and so I’ve been working very closely with my new colleague, Mike Wasko. Mike is a prominent figure within our industry, and this week as we were catching up, we started discussing the...
by Marc Ellison | Oct 13, 2021 | Regulatory Submission, SEND, Sensible SEND
“You wait all day for a bus and then 3 come along at once.” It’s a phrase I used to hear a lot in my younger days when I would often ride public transport. There’s been some of that going on this week, though not with busses. For me, this week it’s been the role of...
by Marc Ellison | Sep 29, 2021 | Regulatory Submission, SEND, Sensible SEND
It was late 2020, during the FDA public webinar, as part of the CDISC face-to-face meeting, that the agency made the simplest of statements, which seemed to turn the world of SEND upside down: “The placement of a study into the eCTD format does not determine...
