As we head into the summer break, it’s time to reflect on events over the last few months and what’s ahead for the autumn.

CDISC Interchange

It’s a busy time for us with our CDISC work. Companies increasingly demand our SDTM and ADaM expertise. In addition we now have new requests to use our A3 Suite. We were delighted to meet old friends and new at the CDISC Interchange. There is a clear interest in the way we are developing Biomedical Concepts and how closely we are aligned with the CDISC 360 project (there will be another article about this next week).  If you want to join our CDISC or A3 team, we have some open vacancies. So if you are looking for a new start, then get in touch.

As always, our team are valued members of the CDISC community. You can see their presentations here. Feel free to get in contact if you have questions or need CDISC support.

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

Johannes Ulander: Understanding the Technical Conformance Guide

Kirsten Langendorf: Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts. NB. Kirsten’s presentation included a video of how to mine the BCs using our MDR, if you want to know more or are interested in how we do this, please get in touch.

And in case you missed them, our vegan wine gum selection will be available at our other events.  We will be back at CDISC, in Berlin, in 2020.

PhUSE Single Day Event, Copenhagen 6 June 2019

As always, we are delighted to support PhUSE, in many aspects of our work. We were sponsors for the SDE in Copenhagen (vegan wine gums may have made an appearance). Kirsten Langendorf and Dorte Straarup provided an overview of the event:

The day was focused primarily on the ADaM standard with five of the ten presentations on ADaM and a variety of approaches discussed and presented. All of them still relying on EXCEL and SAS. It appears that in general ADaM is less strictly managed when it comes to standards compared with SDTM.

There were several other presentations:

  • SEND at Novo Nordisk and how they have had to start from scratch moving from documents to collecting data in SEND and at the same time building up a DM organization.
  • Katja Glass presented an overview of open source tools that could be used in pharma. She stressed the need for good documentation.
  • Andrew Ndikom showed the apps Clinical Metadata have developed (free of charge) to use define for creating SDTM shells and comparing define files.
  • Konstantinos Lymperis, from Larix talked about a scoring function used for ALS patients and the challenge computing it, something that could easily be done in a graph.
  • Finally Jean-Marc gave an overview of the FDA, EMA and Health Canada’s different approached to data sharing and redaction requirements.

As always this was a well-attended and busy event.

PhUSE CSS Silver Spring, Maryland 9 -11 June 2019

Dave Iberson-Hurst attended the CSS meeting where he is part of the Emerging Trends and Technology working group. Discussions around Linked Data and the use of FHIR in clinical research are areas where Dave has considerable experience and expertise. You can read more about the working groups here. There were also excellent presentations by the FDA which you can pick up here. One of the most interesting talks was by Ethan Chen, FDA/CDE. He gave an update on Technical Rejection Criteria for Study Data, giving fascinating feedback on the number of errors that the FDA continue to encounter.

PharmaSug, Philadelphia, Pennsylvania, 16 – 19 June 2019

Carey Smoak, our CDISC SDTM Medical Devices expert, and Thomas Danberg were at PharmSug this week. With 800 attendees and multiple streams, it’s a busy conference. Carey was a section co-chair for Submission Standards.  The stream had 28 papers and two full days were devoted to submission standards, demonstrating the desire for discussion and the need to understand regulatory requirements. Carey also gave a presentation in the Data Standards section, was a panel member in Data Standards, and moderated the panel in Submission Standards.  If that wasn’t enough, he led an informal drop-in discussion about Pinnacle 21 problems and issues.  These activities were all on Monday and Tuesday.

On Wednesday, most of the day was focused on some excellent presentations by the FDA. It was interesting to note that CBER is now more fully engaged with the CDISC standards and coming into line with CDER.

Future Events

Danish Data Managers Association Meeting (DADM) 5 September 2019

The local event is taking place at Leo Pharma and Johannes Ulander will be presenting on CDISC Terminology and keeping up with changes using an MDR. You can find out more here.

NLS Life Science Days, Malmö 10 – 12 September 2019

This is our first-time taking part in the NLS Life Science Days and we’re looking forward to travelling across the Öresund Bridge. You’ll find us doing three presentations and we will be available for discussions and meetings across the event. Find us at Stand 15 in the main exhibition hall. Senior members of our team will be there, so it’s the perfect opportunity to discuss our products and services. We will be releasing more information about this event as it becomes available.

PhUSE EU Connect November 10 – 13 November 2019

In November, we will be back at PhUSE in Amsterdam. We have two presentations at the conference from Dave Iberson-Hurst and Johannes Ulander. Johannes will also be presenting the Linked Data workshop. We are gradually building our presence at PhUSE with AJ de Montjoie now on the conference committee and you’ll see our logo on the conference notepad this year. Of course, we will have our stand where you can come and feast on our wine gums and be able to see the latest exciting developments with our unique software. More details to follow on the presentations.