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...
“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...
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.
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.
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.
Begin considering the systems that collect and report those data and how they may be connecting to your SEND tools. CROs will have far more data and study types that are now modelled in SEND.
