Regulatory Submission Blog

What can our customers control that could help us make SEND faster and cheaper, without negatively impacting quality?

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.

The FDA has released a new version of the study data Technical Conformance Guide

A look at the main SEND discussion points at SOT 2023

When it comes to SEND “What is there to talk about?”, actually quite a lot.

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