Regulatory SubmissionSENDSensible SEND
How creative should we be with SEND?
Marc Ellison
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.
SEND Blog
Regulatory SubmissionSENDSensible SEND
SEND in 2023
Marc Ellison
What the year ahead looks like for the world of SEND.
Regulatory SubmissionSENDSensible SEND
So, was SEND Sensible in 2022?
Marc Ellison
As 2022 ends, Marc reflects on SEND’s progress – from upcoming standards to spirited debates sparked by this blog.
Regulatory SubmissionSENDSensible SEND
Nervous System Tests and SEND: What’s going on?
Marc Ellison
As the nervous system data can be vital to the safety assessment, shouldn’t we include it in SEND?
Regulatory SubmissionSENDSensible SEND
SEND 4.0 – Just how big is this change going to be?
Marc Ellison
In this post, we take a closer look at the scope of changes for SEND 4.0
Regulatory SubmissionSENDSensible SEND
How good is good enough?
Marc Ellison
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.
Stay up to Date
Get expert tips, industry news, and fresh content delivered to your inbox.
