by Marc Ellison | Jul 17, 2024 | Regulatory Submission, SEND, Sensible SEND
It was not that long ago that I would attend conferences and other industry events and be inundated with questions about SEND. Conversations would often start with “Does my study need SEND?” or even “What is a SEND?!”. There would be a sense of déjà vu as I’d often...
by Marc Ellison | Jul 2, 2024 | Regulatory Submission, SEND, Sensible SEND
Predicting the future has a knack for making even the smartest among us look foolish. Remember when tech pundits in the ’90s scoffed at the internet, dismissing it as a passing fad? Fast-forward to today, and our lives are intertwined with the web in ways they could...
by Marc Ellison | Jun 5, 2024 | Regulatory Submission, SEND, Sensible SEND
There’s a juggernaut on the horizon and it’s heading our way. Its ETA may be changing, but we need to prepare for impact. No, this isn’t the pitch for some low-budget 80’s action thriller, I’m talking about the next version of the SEND standard, and this one is a...
by Marc Ellison | Apr 24, 2024 | Regulatory Submission, SEND, Sensible SEND
For this post, I’d like to share the thoughts of my colleague and good friend, Dr Brenda Finney as she has a pretty interesting take on the use and re-use of data in the drug development pipeline. The introduction of SEND has contributed to the proliferation of such...
by Marc Ellison | Mar 22, 2024 | Regulatory Submission, SEND, Sensible SEND
After a brief hiatus, I’m blogging again and there’s a few important things we need to catch up on. The end of 2023 came with a surprise in the form of a Federal Register Notice to inform us that the FDA would require SENDIG-Genetox v1.0 for studies starting March...
