Is there really that much to say about SEND?

Back in 2020 when the idea of blogging about SEND was first suggested to me, my initial thought was “What is there to talk about?”. This is now my 61^st bi-weekly post. If you have been with me along that journey, then you will have spotted a few recurring themes. I like discussing scope, future standards development and how much SEND has changed the nonclinical world. However, more than simply repeating myself, I always feel there is something new to say. Something new to add to the discussion, and I think that is largely driven by having the unique viewpoint of being a vendor.

At Instem we serve organizations large and small; CROs and sponsors; specialists and full-service providers; SEND experts and SEND newbies. Our customers are varied and cover all corners of the safety assessment world. Most CROs have one main data collection system, one well-curated lexicon and a fairly consistent set of SOPs, study designs and tests. Instem is not a CRO. We see a wide variety of study designs, data collection practices and the like. Therefore, we get to see a wide variety of data and each study can feel like a new challenge to wrestle the data into shape.

And that’s just the data we are converting to SEND for submissions. We also provide SEND education and consultancy as well as services like bulk conversions for warehousing and data mining. And aside from SEND services, we also supply software and tools to convert data, view SEND files, generate Define-XML and the nonclinical Study Data Reviewers Guide. So again, when working with our customer’s software needs, we see a wide variety of data collection practices and related systems. We hear the different interpretations of SEND that are prevalent across our industry.

This blog post is not intended to sound like an advertisement for our products and services, rather to explain the unique viewpoint of being a vendor to our industry. Having passed the milestone of 60 blog posts, I think the reason why there’s always something more to discuss is because I’m often talking to a new customer or seeing a new presentation of data or hearing a new viewpoint which provokes a new blog post.

Back in 2020 I could never have imagined that there was so much to talk about but being a vendor keeps things fresh. Also, being a CDISC volunteer keeps me on the leading edge of standards development, and again that often inspires a blog post or two. So, when it comes to SEND “What is there to talk about?”, actually quite a lot.

For anyone attending the Society of Toxicology in Nashville next week, I’ll be co-presenting on the life of a SEND dataset, which includes the challenges and best practices of preparing SEND, and the opportunities that electronic data provide beyond submission. If you are attending, please stop by and say ‘Hi’.

’til next time

Marc