Sensible SEND 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.

With the SENDIG-DART requirement fast approaching, key lessons from the FDA’s pilot highlight just how complex these studies can be, and why preparation matters.