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...
by Marc Ellison | Nov 8, 2024 | Regulatory Submission, SEND, Sensible SEND
Have you heard of ICH S1B (R1)? It’s not currently causing too many waves in the world of SEND, but maybe it should. S1B hasn’t really landed on the SEND horizon yet, so you’d be forgiven for not being fully up to speed with it. Let me give you the 101: This guideline...
by Marc Ellison | Jul 17, 2024 | Regulatory Submission, SEND, Sensible SEND
It was not that long ago that I would attend conferences and other industry events and be inundated with questions about SEND. Conversations would often start with “Does my study need SEND?” or even “What is a SEND?!”. There would be a sense of déjà vu as I’d often...
