Newsletter December 2023


With the festive break just around the corner we thought it would be the perfect time to tell you about a few of our special projects and events from 2023:

  • PHUSE EU Connect in Birmingham
  • A Biostatistics client case
  • Validated deployments of SAS Viya SCEs

Looking back at PHUSE EU Connect 2023

A team from OCS Life Sciences attended the PHUSE EU Connect 2023, which was held from 5 to 8 November in Birmingham. This year, Jules van der Zalm, Kenneth Blokland, Louella Schoemacher and Lieke Gijsbers represented OCS. As always, the conference is being marked by great presentations providing insights on the developments and latest trends in our industry like the potential of ChatGPT (and other large language models) in programming and the usage of open-source solutions. the keynote speakers were very inspirational, addressing topics like diversity, inclusivity, motivation, teamwork, leadership and decision-making in high-stress environments. Very valuable in our day-to-day work.

OCS contributed to the conference with two presentations. Louella Schoemacher presented together with Jasmine Kestemont of Innovion about the implementation of a metadata repository in a fast-growing biotech company, they shared their learnings and future plans. Lieke Gijsbers presented about the preparation of an Integrated Summary of Safety (ISS) and associated submission documents like the integrated Define-XML and Reviewer’s Guides. Both presentations were well-attended and interesting discussions ensued afterwards. Lieke also serves as a stream chair for the Standards Implementation stream. Besides exchanging knowledge, PHUSE EU Connect provides a great opportunity for socialising and networking. We truly enjoyed meeting old and new friends, and look forward to next year’s PHUSE EU Connect in Strasbourg! Hope to see you there!

Our Biostatistical Services – a client case

Since 2021, we have been involved in providing guidance on the best study designs to use, performing sample size calculations, providing statistical input into the study protocols and developing the statistical analysis plans for eight studies for a US based biotech startup. The company plans to develop a drug candidate that could be therapeutically useful as a pro-hemostatic agent to rare hereditary bleeding disorders. During the past two years, it can certainly be said that a strong relationship has developed between us, a relationship built on trust and mutual respect.

Here is what one of the co-founders of the company said about their collaboration with OCS Life Sciences: “OCS is the perfect partner, both for outsourcing biostats production work and for insourcing an experienced biostatistician to serve as member of the core project.”

It is our goal to get such positive feedback consistently from all of our clients – and often we do! If you want to experience what that’s like first hand, you should get in touch with Melanie Schopp.

alidated deployments of SAS Viya SCEs

In a recent milestone achievement, OCS Consulting successfully delivered a groundbreaking project—implementing one of the initial fully qualified and validated Statistical Compute Environments (SCE) based on SAS Viya. SAS Viya, a cloud-based platform introduced in 2016, offers scalability, accessibility, and seamless integration with open-source programming, presenting a significant advancement in the Life Sciences industry.

To meet the requirements of GCP and 21 CFR Part 11, OCS Consulting proposed an innovative solution by aligning SAS Viya with GAMP5’s V-Model. This resulted in the establishment of a qualified and validated SCE, setting a precedent for future implementations. Beyond showcasing the viability of SAS Viya in regulated environments, the project garnered interest from SAS Institute as well as from other clients.

Looking ahead, SAS Viya is lilely to become a preferred solution for Statistical Computing Environments, particularly for companies grappling with open-source programming challenges. OCS Consulting is actively involved in discussions to streamline the validation/qualification of open-source-based SCEs using SAS Viya.

For further insights into this pioneering project or to explore related topics, please read the full article on our website or get in touch with us.