Out with 2020, SEND in 2021
Marc Ellison
As we move into 2021, SEND is evolving; with the SENDIG-DART pilot, updates from FDA, and the long-awaited release of SEND 3.1.1, marking a small but meaningful shift in usability.
Regulatory Submission Blog
Should SEND dictate your choice of CRO?
Marc Ellison
Three years into SEND’s requirement for INDs, it’s clear that SEND has transformed our industry, impacting everything from study placement to data collection and analysis. It’s no longer just a file format; it’s a driving...
The DART pilot is getting ready to fly: Part 2
Marc Ellison
Equipping the industry for the SENDIG-DART Fit-For-Use pilot has been a major effort – balancing software development, service readiness, and a long journey from concept to reality.
The DART pilot is getting ready to fly
Marc Ellison
The FDA’s SENDIG-DART pilot is finally here! This new SEND standard covers Embryo-Fetal Development studies with 7 new domains, building on SEND 3.1. It’s been a long journey from development to this pilot – exciting...
There is nothing permanent except change
Marc Ellison
SEND keeps changing fast. Recently, FDA made it clear that SEND requirements go beyond just studies placed in the eCTD, if a study can be represented in SEND, it should be. This broadens the scope...
SEND: Why did they have to make it so damn hard?!
Marc Ellison
At first, I thought SEND would be simple, just standardizing study data like any other. But it’s far more complex, involving multiple overlapping standards, evolving regulations, and even clinical concepts awkwardly adapted for nonclinical use....
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