by Marc Ellison | Aug 3, 2023 | Regulatory Submission, SEND, Sensible SEND
Have I been repeating myself? I’ve been blogging about SEND since October 2020 and this is my 70th post, so yes, it’s unsurprising that I’ve repeated one or two ideas along the way. There are main topics that keep reoccurring. Subjects that need revisiting partly with...
by Marc Ellison | Jul 19, 2023 | Regulatory Submission, SEND, Sensible SEND
In my last blog post, I described the content of the two new implementation guides (IGs) that CDISC has just published as part of the SEND standard. These are the SENDIG-Genetox v1.0 and SENDIG-DART v1.2. In this post we’ll discuss the submission implications of the...
by Marc Ellison | Jul 5, 2023 | Regulatory Submission, SEND, Sensible SEND
Wednesday, June 28, 2023, was a significant day in the calendar for nonclinical data standardization with not one, but two new SEND Implementation Guides (IGs) plus their accompanying Conformance Rules. The new IGs were SENDIG-DART v1.2 and SENDIG-Genetox v1.0. I’ve...
by Marc Ellison | Jun 30, 2023 | Regulatory Submission, SEND, Sensible SEND
In theory, the relationship between CDISC’s SEND Implementation Guide (IG) and the FDA’s study data Technical Conformance Guide (TCG) is pretty straight forward: CDISC defines the IG and then the TCG communicates “general considerations on how to submit standardized...
by Marc Ellison | Jun 21, 2023 | Regulatory Submission, SEND, Sensible SEND
“We work in one the world’s most risk-averse industries. The entire purpose of safety assessment is to identify risks of experimental new drugs and treatments.” This is often my opening line for the induction of a new team member in my company. I feel it’s an...
