Can a certain study or data type be represented in SEND? The more ‘creative’ we need to get to place data in SEND, then potentially the less useful it is.
What the year ahead looks like for the world of SEND.
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.
