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”
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?”
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?”
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; …
It’s a basic human need: We want our work accepted and valued. Nobody wants to see their work rejected. It’s so obvious, it almost goes without saying. Worse still would be being rejected by a cold, heartless automated computerized system. That would be soul destroying. However, with the FDA’s latest deadline, automated rejections will start …
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 suppliers right across the industry. We got talking about …
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 going to be talking about the Standard …
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 ‘subjective’ the SEND standard is. You …
Continue reading “The pros and cons of having a flexible standard”
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 that sound? In my last post, I touched …
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, this analogue-versus-digital discussion has got me feeling a …
