Regulatory Submission Blog

The Confirmed Data Endpoints for Exchange (CoDEx) is CDISC’s method of addressing the scope for SEND, down to the individual endpoints.

As work continues on the content and updates for SEND 4.0, there’s a definite change in approach in an effort to make study representation more uniform, and to give implementors much clearer direction.

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?