by Marc Ellison | Jul 7, 2021 | Regulatory Submission, SEND, Sensible SEND
This week I caught up with Debra Oetzman from our SEND Services team. As one of the authors of the SEND standard, an active CDISC and a PHUSE volunteer, many of you may have already interacted with her. At Instem, Debra performs verifications of datasets from...
by Marc Ellison | Jun 23, 2021 | Regulatory Submission, SEND, Sensible SEND
It was one of the finest moments of my career, but it didn’t exactly get off to a great start. At the Safety Pharmacology Society, I was invited to speak at the DSI Data Blast (think Safety Pharmacology meets WrestleMania). I introduced myself and explained that I was...
by Marc Ellison | Jun 9, 2021 | Regulatory Submission, SEND, Sensible SEND
I feel I need to make a confession. I need to admit that being a vendor of SEND software and services, drives a strong bias in how I believe the SEND standard should be defined and implemented. In the last couple of postings, we’ve been discussing how flexible, or...
by Marc Ellison | May 26, 2021 | Regulatory Submission, SEND, Sensible SEND
You don’t need me to tell you that SEND is the standard for representing nonclinical data, but what would you think if I told you that just by looking at the data, it’s quite easy tell which software and organization produced the SEND datasets? How ‘standardized’ does...
by Marc Ellison | May 12, 2021 | Regulatory Submission, SEND, Sensible SEND
I hope you enjoyed my last blog post that discussed the differences in the analogue world versus the digital world, and how this gets us into a debate about whether SEND should represent the data we collect, or represent the data we report. Following on from that,...
