Regulatory SubmissionSENDSensible SEND
A picture paints a thousand words
Marc Ellison
Standardized SEND data is unlocking the power of visualization, enabling faster, clearer insights and opening the door to a future beyond static PDFs.
Sensible SEND Blog
Regulatory SubmissionSENDSensible SEND
Beyond Compliance?
Marc Ellison
While many still struggle with SEND, a few are venturing Beyond Compliance, unlocking insights from standardized data with tools like SEND Explorer and breathing new life into legacy studies.
Regulatory SubmissionSENDSensible SEND
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.
Regulatory SubmissionSENDSensible SEND
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.
Regulatory SubmissionSENDSensible SEND
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 SubmissionSENDSensible SEND
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...
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