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.
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.
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.
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.
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...
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.
