Regulatory Submission Blog

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.

Marking 25 years in nonclinical and 10 years with SEND, Marc reflects on how far the industry, and SEND itself, has come, and what lies ahead.