What is the impact of the new FDA Technical Conformance Guide?
Marc Ellison
The FDA has released a new version of the study data Technical Conformance Guide
SEND Blog
Application Areas
Clinical Stage
Product
SEND @SOT 2023: Same, but different
Marc Ellison
A look at the main SEND discussion points at SOT 2023
Is there really that much to say about SEND?
Marc Ellison
When it comes to SEND “What is there to talk about?”, actually quite a lot.
Who uses the CoDEx document anyway?
Marc Ellison
The Confirmed Data Endpoints for Exchange (CoDEx) is CDISC’s method of addressing the scope for SEND, down to the individual endpoints.
Are you ready for a tighter standard?
Marc Ellison
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.
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.
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