This will be my final blog post of 2021, as I’ll be taking a break over the festive season. The season of goodwill is very apt for what’s on my mind this week. Whether it’s media reports of how COVID-19 vaccines were collaboratively developed so rapidly; or the rise of consortia for exchanging pharmaceutical data …
Continue reading “The standard for the altruistic exchange of nonclinical data”
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. …
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 …
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 …
In the last CDISC SEND Core Team meeting, we got to discussing Anti-Drug Antibody (ADA) data, and its representation in SEND. We were debating what we’d recommend, and this is the cause of my conflict. The purist within me wants to scream “Custom Domain!”. The pragmatist knows the industry isn’t ready for this. I want …
It’s here. It’s finally here. It’s actually real. This is going to happen. This is part 1 of a 2 part mini-series, hang in there… I’m referring to the FDA Federal Register Notice for the pilot of SENDIG-DART (that’s SEND for Reproductive Tox). It’s a new SEND standard, and the FDA are going to run …
In my previous blog, I recalled the tale of my first experience with SEND. I’d assumed that standardizing nonclinical data would be straightforward, after all we have standard glossaries and lexicons from the likes of INHAND, and isn’t one 28-day study pretty much like another? Yet, this SEND thing seemed so alien and impenetrable to …
Continue reading “SEND: Why did they have to make it so damn hard?!”
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