At the end of February, S-cubed were on the road again, this time in Baltimore for the second PhUSE US connect and what an event it was.

Being part of the PhUSE family is always a friendly and vibrant place to be. As usual the events team were on hand to support the exhibitors and presenters which is one of the reasons we return year on year to these events. As a very busy company, a decision to attend a conference is not taken lightly, particularly when there are intercontinental flights involved, materials to be moved and staff time and jet lag to factor in. However, we weren’t disappointed. With attendees at over 500 and many new faces, we had a fabulous time, made superb connections and built new relationships.

Dave setting up the A3 Demos at PhUSE

Breaking the data Silos – Thought leaders

Of course, we were not just there as exhibitors, with many industry thought leaders within our company, they are often in demand for discussions and presentations. After settling into the usual conference routine of constantly eating and talking, Dave Iberson-Hurst presented in the Standards Implementation Stream on Tuesday 26th February. Dave is at the forefront of the latest technologies including, linked data and Neo4j, that can improve processes within clinical research, ‘The industry has long talked about ‘end-to-end’ as a way of improving processes within research, but the industry is bedevilled by silos and standards that are hard to use. The presentation describes the progress made in moving towards a world where silos are broken down, standards are easier to deploy, we place the data at the centre of our work, and move towards a world where automation becomes reality.’ In reality, Dave would like us all to hug our data.

“Hug your data,” Dave Iberson-Hurst

Dave has been pushing the industry to use an approach that automates processes across the clinical research lifecycle for many years. Since the early inception of the ‘end to end’ workshops at CDISC, Dave has been a thought leader in improving automated processes. He is always happy to discuss the ideas he develops. Consequently, the booth was surrounded by visitors asking about the way our software works to ease the pain of managing terminology and forms. One visitor, who watched the demonstration of FHIR to SDTM, struggled to understand that with graph technology there was no mapping involved. Quite the revelation.

You can see Dave’s slides here

And read Dave’s paper here

The Harbour Waterfront – Baltimore

Demonstrating the power of the A3 Suite

On Wednesday, Johannes Ulander was presenting in the Software Demonstrations Stream, although with only 20 minutes, Johannes had to prepare a word prefect presentation to cover all the features of the software. His session, Managing Complexity Towards Submission focused on the following:

When making a submission to the FDA or PMDA the creation of the individual deliverables such as the annotated CRF, the SDTM datasets and the define-xml are usually not so complex in themselves. What makes things complicated is keeping everything synchronised and maintaining the traceability between all deliverables in all the included studies. As data might be collected slightly different in the studies, they might also need different representation in the standards, which makes the documentation process heavy as you will need to explain what you have done and why you did it, especially if you are not able to conform to the standards. This presentation will focus on a tool built to help companies be consistent in how standards are implemented and automate the process of creating annotated CRFs and define-xml, even if changes are applied to how the data is collected during the study conduct.

You can see Johannes slides here

If you want to know more about the A3 Suite, MDR or Study Workbench, please contact Adam de Neergaard (adn at s-cubed.dk) and ask for a demo.

Future Events

In the coming months, we will be sending out details about the presentations we are giving at the CDISC Interchange in Amsterdam in May. We were very proud that both the A3 Software team and the S-cubed CDISC team had all their abstracts accepted for this conference:

8th May: Session 3 Track C: Use Cases

Carey Smoak presents: “Pacemaker Guy: De-Mystifying a Business Use Case for SDTM and Medical Device Domains”

8th May: Session 4 Track A: Submissions

Johannes Ulander presents: Understanding the Technical Conformance Guide

8th May Session 4 Track C: End to End

Kirsten Langendorf & Dave Iberson-Hurst: Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts

You can learn about our CDISC services and our software here

Of course, there will be more events and news to be revealed over the coming months, as we are leading some interesting developments in the Nordic Region! Look out for details and updates here. In the meantime, see you in Amsterdam.