In this newsletter:
- Validated R for clinical trials
- Get to know Lieke Gijsbers
- Take the Complexity out of SAS Platform Management
- PHUSE Single Day Event in Cambridge
Validated R for clinical trial analysis and submission
R has been rapidly gaining popularity among statistical programmers for years, if not decades. It's ability to quickly adapt and adopt new statistical methods has played an important role in that. Public resources such as CRAN, Pharmaverse and Bioconductor make these methods accessible through packages that can easily be integrated into your R environment.
Stuck in 15-year-old workflows
We still see many companies using RStudio on local laptops, a workflow very similar to how SAS Display Manager was used on local machines 15 years ago. Users get the flexibility (and, granted, the luxury) of installing whatever package they need. Many of us blindly trust these packages and will not perform much validation. In a regulated environment that is not acceptable. Auditors, inspectors, and your QA/CSV team will want to verify that each and every package is both safe and reliable.
OCS Life Sciences has developed an implementation plan and governance model for the deployment of validated R environments. Based on a Posit stack (including Workbench, Connect, and Package Manager) running on qualified infrastructure, our plan provides a controlled environment for programming in R, that allows programmers to produce reliable and reproducible results with ease.
A modern approach to an old problem
Our approach moves away from the traditional "shared server" model in favour of a containerised "project-in-a-box" architecture. Each time you launch a new session, it spins up a new, sterile virtual environment. Mechanisms are in place to ensure you get the same R version and the same package versions as yesterday (or 5 years ago), and there is no cross-contamination from other projects. Virtualisation with Docker and orchestration through Kubernetes provides security and scalability.
Our implementation plan revolves around the traditional, yet still very relevant, tiered environment setup. The production environment is strictly controlled and R packages are made available only after thorough verification. The validation environment is where packages are tested and verified. The development (or sandbox) environment is non-validated, although R packages must still undergo some level of testing to ensure they're not harmful to the system.
Removing the validation bottleneck
This structured approach removes the 'validation bottleneck' that often plagues life science companies. By automating the environment setup and centralising package governance, we allow your data scientists to focus on science rather than system configurations. The result is a future-proof foundation that satisfies both the need for rapid innovation and the rigorous demands of GxP compliance.
Modernise your R infrastructure today
Transitioning to a validated R environment doesn’t have to be a hurdle for your team. OCS Life Sciences is ready to help you bridge the gap between innovation and compliance. Contact us today to request a formal presentation of our R implementation plan and discover how we can tailor this framework to your organisation’s specific regulatory requirements.
Get to know Lieke Gijsbers
Lieke Gijsbers joined us in 2016, fresh from her PhD in Nutritional Epidemiology and with a clear ambition: to puzzle with data.
She started out on complex clinical data projects and quickly developed strong expertise in CDISC. What began with hands-on project work soon expanded into delivering trainings, presentations, and supporting clients across a wide range of assignments. Within months, Lieke was already confidently training others on SDTM, a topic that had been brand new to her not long before. Calling her a fast learner would be an understatement.
Over the years, Lieke has been involved in numerous initiatives across clients and teams, combining deep technical knowledge with a clear, practical way of working. Today, she oversees all projects and opportunities within Clinical Data Science, ensuring quality, consistency, and forward momentum.
Recently, Lieke was elected as a member of the Europe CDISC Coordinating Committee (E3C) for the 2026-2029 term. In this role, she will support CDISC activities in Europe, contribute to collaboration with European organisations, and be involved in key initiatives such as the annual European CDISC conference. This appointment recognises her expertise and further connects day-to-day practice with the future of clinical data standards.
Take the complexity out of SAS platform management
Managing SAS environments like SAS Viya, SAS 9.4, or SAS Life Science Analytics Framework (LSAF) requires time, expertise, and ongoing attention. For many organisations, these demands can stretch internal teams and divert focus from core business objectives.
We help solve that.
Through our SAS Managed Services, we provide reliable, proactive support for the full SAS stack — keeping your platforms secure, high-performing, and up-to-date. These services are already in place for several clients across various sectors, and we’re ready to support new organisations looking for peace of mind in their analytics operations.
What our managed services include:
- Monitoring & Maintenance
Oversight, patch management, and issue resolution to ensure platform stability - User & Access management
Secure, role-based access with streamlined user administration - Backup & Disaster recovery
Data protection strategies tailored to your compliance and business continuity needs - Upgrades & Migrations
End-to-end support for transitioning to newer versions or cloud-native SAS Viya - Operating system support
Linux support, specifically when the rest of the organisation runs Windows
Why organisations choose us
We bring years of expertise and passion in managing SAS platforms in both on-premise and cloud environments. Our team understands the technical, operational, and regulatory requirements involved - especially in complex or validated environments like Life Sciences.
Our clients benefit from reduced downtime, more predictable performance, and fewer operational burdens on internal IT teams.
Ready to strengthen your SAS environment?
If you’re looking to simplify the day-to-day management of your SAS platform, or planning an upgrade or migration, Please contact us using the button below so we can schedule a meeting.
PHUSE Single Day Event in Cambridge
On February 19th, the next PHUSE Single Day Event will take place in Cambridge, UK. The theme of the event is “Seamless Collaboration in Pharma and CROs: Harnessing Innovation, AI-Enabled Coding, and Expertise for Harmonious Partnerships.”
At this event, industry experts will share practical insights on how AI-driven coding, innovation, and collaborative partnerships are transforming clinical development. Register here for the event.
In addition to attending with a delegation from our team, OCS Life Sciences will also be giving a presentation. Our colleagues Stephan van Driel and Ajay Sundaresan will present on the topic: Human-in-the-Loop (HITL) AI for Software Development: Insights from an implemented Clinical Project.
You can read the full abstract via the button below. We hope to see many of you there! If you can’t attend the event but are interested in this presentation, please feel free to get in touch with us.
