As 2022 ends, Marc reflects on SEND’s progress – from upcoming standards to spirited debates sparked by this blog.
As the nervous system data can be vital to the safety assessment, shouldn’t we include it in SEND?
In this post, we take a closer look at the scope of changes for SEND 4.0
Some still believe that if a SEND submission passes the FDA’s Technical Rejection Criteria (TRC), that’s “good enough.” But this dangerously underestimates the role SEND plays in safeguarding first-in-human studies.
At the Fall 2022 CDISC meeting, the spotlight was on using SEND beyond compliance – highlighting virtual control groups, cross-study analysis, and the upcoming major release of SENDIG 4.0.
Standards development can feel slow, but as SEND 3.2 shows, going together brings greater rigor, collaboration, and long-term value.
