by Marc Ellison | Jun 12, 2025 | Regulatory Submission, SEND, Sensible SEND
I met up with a fellow CDISC volunteer at the Society of Toxicology meeting recently, and during the general chit-chat, he mentioned that he had reviewed SEND v4.0 but wasn’t really considering its impact yet. Me, on the other hand, I told him it was already...
by Marc Ellison | May 29, 2025 | Regulatory Submission, SEND
The Standard for the Exchange of Nonclinical Data (SEND) is essential for organizations submitting nonclinical study data to the FDA. Although standardization and implementation guides are helpful, it can still be unclear when SEND applies. Implementing SEND can be...
by Marc Ellison | May 16, 2025 | Regulatory Submission, SEND, Sensible SEND
Ever since I started working on SEND, there was frustration with the requirement to use SAS transport file as the file format. Over the years CDISC, PHUSE and FDA all tried to push forward with alternatives. Does anyone remember experimenting with Dataset -XML? Last...
by Marc Ellison | Jan 6, 2025 | Regulatory Submission, SEND, Sensible SEND
It’s the start of the new year, and so it’s only human to look to the year ahead with a sense of optimism. So, it will come as no surprise that my first blog post of the year looks at what we may expect to be happening in the world of SEND. Our first major milestone...
by Marc Ellison | Dec 17, 2024 | Regulatory Submission, SEND, Sensible SEND
I often tell people that I work in the world’s most risk-averse industry. An industry that only exists to identify risks in new pharmaceuticals and chemicals. And I love it. Why? Because I get to work with the smartest, most dedicated individuals who are driven to...
