Being the first post of the year, I thought it would be good to consider what the year ahead looks like for the world of SEND. The obvious place to start is looking at the standards that are going to become required by the FDA for submission. March will see SEND 3.1 become required for …
Author Archives: Marc Ellison
So, was SEND Sensible in 2022?
Greetings of the season everyone! As this will be my last post of the year, I thought it would be interesting to look back at a few of the topics featured in the blog during 2022. Back in January I was hoping to see the publication of the SEND standards for juvenile toxicology (SENDIG-DART 1.2) …
Nervous System Tests and SEND: what’s going on?
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 was presented, and so …
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SEND 4.0 – Just how big is this change going to be?
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 …
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How good is good enough?
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 on the fact that the FDA’s Technical Rejection Criteria (TRC) …
Virtual Control Groups and more – Update from the CDISC Fall meeting
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 to this topic and the opportunity to use SEND beyond just …
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Go Together
“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 see the …
SENDIG-DART is more tricky than regular SEND
I write this as I arrive at the European Teratology Society in Antwerp, Belgium to present a poster relating to the SENDIG-DART. This feels significant for a couple of reasons. Firstly, and personally, this is my first in-person conference or meeting since the COVID lockdown. To be travelling for business really feels like things are …
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Reflecting on the last 10 years of SEND
Spoiler Warning: This week’s blog post is even more self-indulgent than usual. I’m recognizing two very significant anniversaries in my professional career. This month marks 25 years of working in the nonclinical space. September 1997 saw me take a programming job at a preclinical software vendor, fully in the expectation that it would be a …
New standards on review
The CDISC SEND team have several new standards edging their way towards publication. The SENDIG-Genetox is the CDISC SEND standard for the representation of in vivo genetic toxicology studies. This has completed an internal CDISC review and should soon be heading to a full public review. For those unaware, this first version of SENDIG-Genetox focuses …
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