As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies by. So yes, time is most definitely relative. …
Category Archives: Uncategorized
Happy thanksgiving!
As my friends on the other side of the Atlantic are busy giving thanks this week, I thought it was best to postpone this week’s blog post. Normal service will be resumed next week. See you then! Marc
FDA provides more detail on the Scope of SEND
This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As …
Continue reading “FDA provides more detail on the Scope of SEND”
What’s the deal with the eCTD Study Tagging File (STF), SEND and the Technical Rejection Criteria?
As you are probably aware, Instem recently acquired PDS Life Sciences and so I’ve been working very closely with my new colleague, Mike Wasko. Mike is a prominent figure within our industry, and this week as we were catching up, we started discussing the question: What is the relationship between the eCTD Study Tagging File …
Is SEND the key to unlocking Historical Control Data?
“You wait all day for a bus and then 3 come along at once.” It’s a phrase I used to hear a lot in my younger days when I would often ride public transport. There’s been some of that going on this week, though not with busses. For me, this week it’s been the role …
Continue reading “Is SEND the key to unlocking Historical Control Data?”
Is the latest Technical Conformance Guide update, the most important to date?
It was late 2020, during the FDA public webinar, as part of the CDISC face-to-face meeting, that the agency made the simplest of statements, which seemed to turn the world of SEND upside down: “The placement of a study into the eCTD format does not determine the SEND requirement” It was just one little line …
Continue reading “Is the latest Technical Conformance Guide update, the most important to date?”
Why Define-XML files give me the Happy Mondays
During my formative years, there was a band from the north of England, not far from where I was growing up, called the Happy Mondays. Probably the most notable thing about them was one bandmember called ‘Bez’. His contribution was somewhere between cheerleading and performance art, as all he appeared to do was dance like …
Continue reading “Why Define-XML files give me the Happy Mondays”
Can SEND datasets be fully compliant…but still wrong?
In a recent post, we discussed how there’s quite a bit of emphasis at the moment on ensuring SEND datasets are compliant with the SEND Standard. Obviously, the main driver here is the activation of the FDA’s technical rejection criteria, which will result in the agency automatically rejecting applications which do not meet the required …
Continue reading “Can SEND datasets be fully compliant…but still wrong?”
Did you see the recent paper from the JPMA SEND Taskforce Team?
Okay, first – some context… Without the FDA requiring SEND datasets, we would not have seen the industry-wide adoption and implementation of the standard. The change made by the industry, continues to fascinate me, in terms of both speed and scale. This drive for submission provides us with a well-defined standard, and one that is …
Continue reading “Did you see the recent paper from the JPMA SEND Taskforce Team?”
There’s a theme developing here
Human beings have an inherent ability to see patterns in everyday objects, like recognizing shapes and faces in clouds. While that might seem ridiculous, pattern recognition is vital for us. Without it, we would not be able to do things as varied as being able to recognize faces; find the answers in a Word Search; …
Sensible SEND Blog 