Beyond Compliance?

Beyond /bɪˈjɒnd/ Preposition “more extensive or extreme than; further-reaching than.”

This week I have been writing the abstract for my talk at this year’s SOT meeting. Even though the event is again virtual, as you may have guessed by now, I’ll take any opportunity to inflict my opinions about SEND on anyone who’ll show up to listen. In writing the abstract, I think back to previous SOT expos and I’m reminded that across our industry, we are a wide and varied crowd when it comes to SEND.

There are still a significant number who are asking “What is this SEND thing, and does my study really need it?”. There are also the Many and the Few. The Many are up and running with SEND, but for them, it is harder than they imagined, more expensive and it’s slow. Oh boy, does it slow things down sometimes! In an industry where time, speed and expertise are often in short demand, the last thing anyone needed was something like SEND. Right?

Then there are the Few. Those exploring the opportunities of standardized study data. The small number for whom SEND is not a burden, it’s just a mechanism by which they can unlock a world of new possibilities.

The Many may have heard talk of this mythical place Beyond Compliance, but the Few are already heading out on the journey of exploration.

So, is there a SEND El Dorado that lays beyond compliance? Certainly, Big Pharma believe so. We can see their investment in consortia where they are pooling their knowledge and building warehouses of shared study data in SEND format. Obviously, such activity comes with considerable investment, and they would only do this if their belief was that the benefits and opportunities outweigh the cost.

However, we don’t have to be part of an exclusive consortia in order to see the benefits of working with standardized electronic data. Visualization tools like SEND Explorer allow regulators, sponsors, and others to interact with nonclinical study data in a fast, dynamic way. Previously, hours would have needed to be spent leafing through PDF pages of a study report, but now we click a button and graphs, charts and other visualizations can appear. See something interesting? Then just another click or two and we are drilling down so see what’s really going on in the study. Or zoom out and summarize to a higher level: Look across a set of studies to see if trends are consistent from study to study, or is there something peculiar about this one particular study?

It doesn’t matter which CRO supplied the data, it’s standardized. It doesn’t matter which collection system was used, it’s standardized. That standardization has allowed for tools like SEND Explorer.

However, that means that their value can only be seen when they are fed a good volume of standardized data.  I’ve often heard the opinion “Wow, that looks great, but I just don’t have enough SEND Data to make use of it”. I’ve spoken to those who know they have a wealth of historic study data, that they would love to be able to use with SEND Explorer, but unfortunately those study data are stuck in PDF. So, the challenge became: how to be able to scrape data from PDFs into SEND in order to feed the warehouses and visualization tools? The vast number of CROs can’t entertain doing this work. Understandably, they are grappling with the challenges of today, without trying to unlock the study data of the past. However, for those who are endeavoring to pitch camp in this land of Beyond Compliance, we’ve developed the tools and techniques to do just this. And we are doing it, today. In parallel with our work converting data for submission, we are also handling data that are going Beyond Compliance.

You can probably tell that I’d be quite excited to have my SOT presentation focus on the possibilities of the land beyond compliance, but I acknowledge that I need to deliver something that is going to be as relevant for the Many as well the Few.

Till next time…..

Marc