Intel, insight and opinions from SEND Specialist (Nerd), Marc Ellison

Welcome to Sensible SEND 

We hope you’ll bookmark the blog and check back often. Look for new posts every other Wednesday offering insights and expert opinions to help you navigate the challenges and opportunities that arise from the SEND standard.

Is the latest Technical Conformance Guide update, the most important to date?

It was late 2020, during the FDA public webinar, as part of the CDISC face-to-face meeting, that the agency made the simplest of statements, which seemed to turn the world of SEND upside down: “The placement of a study into the eCTD format does not determine the SEND requirement” It was just one little line …