Recently, I asked one of our Senior Information Scientists, “If a customer asked you what they could do to make data easier to convert to SEND, what would you say?” Honestly, I was expecting maybe two or three bullet points of slightly vague suggestions. What I got was about three pages of very specific and detailed recommendations. Oh, and he barely had to think about it. Didn’t need time to go away and contemplate, just rattled off the list immediately.

Before I share some of those details, let me first provide a little context. Our customers are a mixture from all sides of the industry: both sponsors and CROs; from very small to very large; from experienced in SEND to complete SEND newbies; from those with a strong SEND capability using us for their overflow, to those who have no in-house SEND capability. Whoever they are, they are supplying us data and receiving back a submission-ready SEND package.

However, one commonality is that we would all like more efficient SEND production, without compromising quality. To that end, we are committed to continual process improvement, tool improvement and we invest heavily in training and staff development, doing what we can with the things that are within our control. But what about the things outside of our control, namely the data supplied?

And this was the point of my question. What could our customers do to help themselves? What can they control that could help us make SEND faster and cheaper, without negatively impacting quality?

Let’s start with the PDF study report itself. Whether we are extracting the data directly out of the tables in the PDF or converting data from a system and then comparing back to the study report, we are constantly working with the PDF study report. Often, we run into issues with the way the PDF has been created. Without things like present and correct bookmarks and hyperlinks, the process really slows. The same is true if there are text sections or tables that are not fully searchable. Oh, and page orientation can be a big deal too. Imagine QC’ing a SEND dataset and comparing results back to the PDF tables when some are landscape and some are portrait, but the PDF has been rendered in such a way that it doesn’t orientate correctly on screen. Such a simple thing, but it really impacts the efficiency of the QC process.

These were just the first few items that related to the PDF, but let’s quickly mention some of the issues we see when converting data from a data collection system or Excel file. You’d be surprised how often we still see modifiers and other important information captured simply as comments. Comments that would need to be read by a conversion consultant and then parsed out to ensure that the correct piece of the data was placed in the correct variable. For each result. For each subject. This is a common scenario, particularly in relation to: chronicity, specimen condition, BLQ values or laterality.

Again, this was just one issue from a list of things he told me. So, for anyone working with a SEND provider, with a desire to have SEND produced faster and cheaper, then I’d highly recommend talking to your SEND partner and seeing what recommendations they have for improving efficiency. Often small tweaks to data collection can have a big impact downstream.

I’d like to thank my friend, Sagar Hadawale, with his help on this particular post.

‘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.