Two years after the FDA clarified SEND requirements, questions still linger, especially for less-typical studies and how far customization can go.
SEND and SDTM look strikingly similar, but are we truly leveraging their alignment to connect nonclinical and clinical insights?
SEND has come a long way since 2012, now more complex, but with better tools, training, and support for those just diving in.
Define.xml is often overlooked in nonclinical submissions, but with the right mindset and tools, it can become a powerful asset for regulatory review.
Lessons from the SENDIG-DART Fit-For-Use pilot reveal just how nuanced DART studies can be, especially when it comes to representing timing concepts like Gestation Day.
At the latest FDA–CDISC webcast, what wasn’t said about SEND scope may speak louder than what was, reinforcing the agency’s expectation for full compliance.
