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 little nostalgic. If like me, you are of a certain vintage, then I’m sure you can remember having to travel to a VHS rental shop if you wanted to enjoy a movie for the evening; or having to wait days to have your photos developed. Back then, living in an analogue world without streaming, meant things took time.

Yet now, it seems that the whole world has got faster due to digital data and standardized formats. So why are we hearing about studies getting stuck in the SEND Traffic Jam? Why are we seeing wait times for SEND conversions increasing and some organizations seeming to have an ever growing SEND backlog?

At a recent industry meeting, the FDA asked about the impact of SEND and the amount of time it is taking to convert a single study. While Instem’s average is 4 weeks, the consensus was an average of 8 weeks of elapsed time.

Living in the digital world, we are expecting things to be faster, not slower, so why are we seeing this extra time needed after the creation of the antiquated analogue appendices?

So clearly, we are talking about safety assessment data and not simply our holiday photos. As such, SEND datasets are not naively accepted as they first roll out of the machine. They’re checked for accuracy, compliance and human beings decide if the data are rendered in a way that best suits the study. This subjective element is often the most time consuming, and that’s because interpretation of the SEND standard itself, is highly subjective.

These are just some of the factors, and all of these things take time. So, there are good, legitimate reasons to explain why SEND conversions are not as instant as simply streaming Netflix on a Friday night. It’s more like restoring an old 35mm movie into a high-definition multi-media experience. Just like SEND, it requires time, expertise and the results can certainly vary in quality.

Organizations have more choices than ever, including internal IT departments for creating SEND. It’s vital that they have the right SEND partners and collaborators to ensure they are meeting the requirements of sponsors, the FDA and any other consumers of the data.

As always, if you’d like to continue this conversation, or have a topic you’d like me to address, drop me a line.

Till 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.