Regulatory SubmissionSENDSensible SEND
The headache of clinical signs
Marc Ellison
Can we standardize clinical signs data for cross-study analysis, or is the variability just too great? A bold new proposal sparks debate.
SEND Blog
Regulatory SubmissionSENDSensible SEND
Still confused about the scope of SEND?
Marc Ellison
Two years after the FDA clarified SEND requirements, questions still linger, especially for less-typical studies and how far customization can go.
Regulatory SubmissionSENDSensible SEND
Everyone is talking about it, but is anyone doing it?
Marc Ellison
SEND and SDTM look strikingly similar, but are we truly leveraging their alignment to connect nonclinical and clinical insights?
Regulatory SubmissionSENDSensible SEND
Thinking about the challenges facing today’s SEND newbie
Marc Ellison
SEND has come a long way since 2012, now more complex, but with better tools, training, and support for those just diving in.
Regulatory SubmissionSENDSensible SEND
Who cares about Define files anyway?
Marc Ellison
Define.xml is often overlooked in nonclinical submissions, but with the right mindset and tools, it can become a powerful asset for regulatory review.
Regulatory SubmissionSENDSensible SEND
So, what did we learn from the FDA’s DART Fit For Use Pilot?
Marc Ellison
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.
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