SEND may not be everyone’s passion, but for those of us who love it, we’re here to ensure standards are met, so others don’t have to worry.
Key SEND milestones in 2022 include the long-awaited SENDIG-DART update for Juvenile Tox and the first SENDIG-GeneTox release—both aligning more closely with evolving FDA guidance.
As data exchange gains momentum in pharma, SEND could play a key role, but practical challenges like scope, effort, and value still need addressing.
SEND may feel fast or slow depending on your perspective, but for those driving its progress, the pace can feel glacial despite years of dedicated effort.
At the recent CDISC SEND meeting, the FDA clarified that SEND is mandatory for applicable studies, regardless of factors like GLP status or eCTD section, reaffirming its critical regulatory value.
Ensuring alignment between the Study Tagging File and SEND datasets is now critical; miscommunication can lead to technical rejection, highlighting the need for better collaboration across teams.
