Regulatory Submission Blog

SEND may seem dry to outsiders, but for those immersed in it, it’s a passion, fueling precision, efficiency, and a shared dedication to getting it right.

SEND’s flexibility allows broad adoption, but as a vendor, I can’t help wishing it were more rigid. Consistency would make tools easier to build and data easier to compare.

Despite being a standard, SEND’s flexibility means everyone does it slightly differently, making it a “subjective standard” in practice.

In a digital world where speed is expected SEND still takes time, because quality, compliance, and subjective interpretation demand more than just pressing “convert.”

SEND sometimes mimics reported data rather than collected data – like a digital camera’s fake shutter sound mimics the real thing – raising the question of whether these “skeuomorphs” belong in our datasets or not.

March 2021 was huge for SEND – with FDA enforcing Technical Rejection Criteria, releasing new guidance, and CDISC publishing updates.