What happens when SEND escapes Toxicology?
Marc Ellison
If we want AI to help us search, analyze and identify patterns in scientific data, giving it consistently structured data seems like a pretty good starting point.
Sensible SEND Blog
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Webinar Recap: When SEND Quality Matters Most
Instem Team
Our recent webinar, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets...
What the FDA Webcast Revealed About SEND (and Why It Matters)
Marc Ellison
“For the first time, the FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. Just a clear statement that quality matters, and that poor SEND has...
An Easy Guide to Reviewing SEND v4.0
Marc Ellison
SEND Implementation Guide v4.0 is the biggest change I’ve seen to the standard in the 15 years I’ve been involved. Here’s what you need to know.
Which industry tools are ready for Dataset-JSON v1.1?
Marc Ellison
While there are great open-source resources out there, in the nonclinical world, we prefer fully commercially available, supported, validated tools from trusted vendors in the space.
I read all the FDA feedback on Dataset-JSON, so you didn’t have to!
Marc Ellison
Marc Ellison, Director, Regulatory Solutions, takes a closer look at the FDA feedback on the new CDISC standard: Dataset-JSON v1.1 as a replacement for XPT files.
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