I make no secret of how much I love working with the SEND standard. I really enjoy both the time I donate to CDISC to help develop the standard; and the time I spend helping develop solutions that allow organizations to create and consume SEND datasets. This year marks my 10-year anniversary of working with SEND. Back in 2012, I attended my first CDISC conference, and I’ve discussed in this blog, how strange that experience was.

Prior to that meeting, I would have never believed that I’d devote the rest of my career to the world of data standards. “Data Standards”, even the phrase itself sounds dull and boring. Could there be anything less creative, less inspiring than “Data Standards”? Yet for some reason, I love nothing more than debating the best way to standardize the representation of nonclinical data.

Without seeing firsthand two individuals passionately argue opposing opinions on SEND, it’s hard to imagine that anyone could get so worked up about such things, but these debates happen all the time. And I love them.

And I’m not alone. Many organizations in our industry have individuals just like me, who care deeply for SEND. Who want to see their organization creating the best quality datasets possible, to provide the FDA with the cleanest, clearest data so the reviewer can focus on evaluating the safety, and not waste time grappling with poorly rendered data. We see SEND as vital to helping bring about faster and safer products, and that’s something that touches everyone.

I know many that read my blog, are equally SEND obsessed. It’s good to know we are amongst friends.

I also know that there are many who read this who are only on the fringes of SEND. Those who may be reluctantly engaging with the standard simply because they can escape it no longer. They do not share the passion or obsession. Understandably, their interests lay in other areas, and SEND is simply an additional burden.

Every organization needs a SEND obsessive. Either their own SEND nerd, or a partner who can just deal with all of this ‘SEND stuff’ for them. They need them, so that everyone else can take comfort in knowing that there’s at least one person that’s taking care of this. Worrying about the SEND datasets so others don’t have to. Ensuring that the next looming regulation date is going to be met. Pouring over every update to the FDA’s Technical Conformance Guide and making sure their organization remains compliant.

So, yes when it comes to SEND, there are obsessives, but it’s not everyone’s cup of tea. Fortunately, there are enough of us who love to nerd-out on this stuff, that everyone else can rest assured that someone, somewhere, is taking care of it.

‘Til next time,


Published by Marc Ellison

Self-confessed SEND nerd who loves geek-ing out about everything to do with SEND. Active CDISC volunteer and member of the CDISC SEND extended leadership team. Director of SEND solutions at Instem responsible for all our industry leading SEND products and services.

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