ADA & SEND: I’m conflicted
Marc Ellison
SEND doesn’t yet support Anti-Drug Antibody data, and while custom domains offer a solution, most of the industry isn’t ready, leaving experts like Marc caught between progress and practicality.
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SEND verses the Study Report
Marc Ellison
SEND was once “just an electronic study report” but today, it’s clear that SEND often goes beyond the report, with data collection and presentation shaped by the standard itself.
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.
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...
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