In November 2026, two sessions will bring together industry experts to share their experiences and perspectives on innovation within the Life Sciences sector. On 16 November, Menco Bakker (Validated Cloud), Anton Meshcheriakov and Jules van der Zalm (OCS Life Sciences) will host a 30-minute session focusing on key developments and best practices.
Later that week, on 18 November, Tom Smeets (OCS Life Sciences) and Mr. Filip Beeldens (argenx) will join forces for another engaging discussion, offering valuable insights from both industry and customer perspectives. Don’t miss these opportunities to learn from experts in the field.
The Missing Foundation of Inspection-Ready Statistical Computing Environments
A Statistical Computing Environment (SCE) can be seen as a layered architecture, with infrastructure as its foundation: servers, storage, and networking. Compliance gaps in this foundation propagate upward, making every control built on top more difficult to implement, validate, and defend during regulatory inspections.
When for example the storage lacks versioning and access logs, an audit trail for dataset changes must be constructed via procedural workarounds, which increases implementation scope and reduces traceability. Despite this, the infrastructure layer is frequently treated as technical background during SCE design, selected before business and regulatory requirements are fully translated into system designs.
We believe this sequencing is a root cause of validation debt that surfaces late and costs disproportionately to fix. Drawing on real-world SCE implementations, we present IT and CSV leaders with a systematic approach to connect GxP requirements directly to infrastructure design decisions, illustrated with concrete examples of compliance gaps.
16 November 2026 16.30 – 17.00 GMT
By: Menco Bakker (Validated Cloud), Anton Meshcheriako and Jules van der Zalm (OCS Life Sciences)
Integrating unstructured exploratory biomarker data using CDISC SDTM standards
Exploratory biomarker (EB) data are increasingly collected alongside clinical trial data to support hypothesis generation on disease mechanisms and treatment response, but are typically not intended for regulatory submission. In practice, EB data arrive from multiple vendors in varied, non-standard formats, creating significant barriers to efficient and reproducible analysis.
To address this, we applied CDISC principles and adapted SDTM to create a fit-for-purpose, catch-all Biomarker (BM) Findings domain tailored to exploratory use. This approach standardizes EB data while prioritizing usability for scientists and statisticians, and enables straightforward integration with existing submission-ready SDTM and ADaM datasets to support cross-domain analyses.
Although designed for exploratory use, the BM structure also facilitates conversion into submission-ready domains should the need arise. This presentation outlines the design decisions, implementation strategy, and lessons learned when adopting CDISC standards for high-volume, multi-vendor exploratory biomarker data.
18 November 2026 | 11:00 – 11:30 GMT
By: Tom Smeets (OCS Life Sciences) and Mr. Filip Beeldens (argenx)