by Marc Ellison | Mar 2, 2022 | Regulatory Submission, SEND, Sensible SEND
Hey everyone – I’ve asked Christy Kubin over at Charles River Laboratories to share some of her thoughts here on Sensible SEND. As well as being a long term CDISC volunteer and co-author of the SEND IG, Christy now leads the SEND Conformance Rules Team and like me,...
by Marc Ellison | Feb 16, 2022 | Regulatory Submission, SEND, Sensible SEND
This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko who leads the CDISC team developing the SEND standard for Genetic Toxicology. I asked him “What is the current scope and timeline of the SEND Genetox Implementation Guide?”, and here’s what...
by Marc Ellison | Feb 2, 2022 | Regulatory Submission, SEND, Sensible SEND
I make no secret of how much I love working with the SEND standard. I really enjoy both the time I donate to CDISC to help develop the standard; and the time I spend helping develop solutions that allow organizations to create and consume SEND datasets. This year...
by Marc Ellison | Jan 19, 2022 | Regulatory Submission, SEND, Sensible SEND
Looking forward to the significant events and milestones that lay ahead over the next 12 months for SEND, barring any major issues, we should see the publication of the next version of the SENDIG-DART. That is the CDISC SEND standard for Reproductive and Developmental...
by Marc Ellison | Dec 15, 2021 | Regulatory Submission, SEND, Sensible SEND
This will be my final blog post of 2021, as I’ll be taking a break over the festive season. The season of goodwill is very apt for what’s on my mind this week. Whether it’s media reports of how COVID-19 vaccines were collaboratively developed so rapidly; or the rise...
