by Marc Ellison | May 24, 2023 | Regulatory Submission, SEND, Sensible SEND
Recently, I asked one of our Senior Information Scientists, “If a customer asked you what they could do to make data easier to convert to SEND, what would you say?” Honestly, I was expecting maybe two or three bullet points of slightly vague suggestions. What I...
by Marc Ellison | May 10, 2023 | Regulatory Submission, SEND, Sensible SEND
This week’s blog will cut straight to the chase: The scope of SEND 4.0 has significantly increased of late, and so the timeline has been impacted too. That means in the next update to the main Implementation Guide, we are getting 8 new domains: Cell Phenotyping (CP)...
by Marc Ellison | Apr 26, 2023 | Regulatory Submission, SEND, Sensible SEND
There’s been some significant news since my last blog post. Firstly, the FDA released a new version of the study data Technical Conformance Guide (TCG), and then we had the combined CDISC and FDA public webcast where some major changes to SEND 4.0 were announced. The...
by Marc Ellison | Mar 29, 2023 | Regulatory Submission, SEND, Sensible SEND
After my 4 years away, I finally got a Society of Toxicology (SOT) meeting in person again, and while much of it felt familiar, I was surprised by just how different some things were: How much our industry has moved on in those 4 COVID-impacted years. The event felt...
by Marc Ellison | Mar 15, 2023 | Regulatory Submission, SEND, Sensible SEND
Back in 2020 when the idea of blogging about SEND was first suggested to me, my initial thought was “What is there to talk about?”. This is now my 61st bi-weekly post. If you have been with me along that journey, then you will have spotted a few recurring themes. I...
