Regulatory SubmissionSENDSensible SEND
Latest updates on SEND v4.0
Marc Ellison
With the new Implementation Guide due to go on public review this coming August, we take a closer look at the scope of SEND 4.0.
SEND Blog
Regulatory SubmissionSENDSensible SEND
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
Regulatory SubmissionSENDSensible SEND
SEND @SOT 2023: Same, but different
Marc Ellison
A look at the main SEND discussion points at SOT 2023
Regulatory SubmissionSENDSensible SEND
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.
Regulatory SubmissionSENDSensible SEND
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.
Regulatory SubmissionSENDSensible SEND
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.
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