Towards an optimal clinical data flow
Our aim is to efficiently utilize knowledge and innovate technology for effective and efficient use of clinical data in order to reduce both time to market as well as costs for drug and device development.
We offer full services and consultancy in data lineage, digitization, standardization, and real-world data utilization for regulatory purposes. We do this from a holistic perspective by including the stakeholders and taking into account existing processes and standards. This includes USDM implementation and validation and real-world data implementation and validation.
Ready to improve? We are happy to share our ideas and thoughts with you. Visit our contact page, send an e-mail to info@clinline.eu or subscribe to our monthly newsletter to learn more.
Knowledge Centre
BREAK&LEARN WEBINARS
Our Break & Learn webinars, are dedicated to subjects related to the digital data flow. They bring you basic knowledge, deep dives and examples of the digital data flow aspects like data lineage, USDM implementation, data flow optimization and real-world data utilization.
These 30-minute webinars are free and a short break of your daily work. Like to learn more? Have a look at our Break & Learn Webinar page.
PRESENTATIONS AND RECORDINGS
Our expert presentations are available via multiple channels. Our archive contains a summary of our past presentations, the corresponding recordings, and/or white papers.
Learn more about the insights shared at the PHUSE EU Connect 2025 in Hamburg. Our white paper “Using CDISC USDM and BCs to Select Data from Alternative Data Sources for Regulatory Purposes” provides a clear and practical deep dive into the topic.
Click to explore the full paper and gain valuable perspectives.
TOOLS AND DOCUMENTATION
ClinLine is developing open source tools that will help you in your digital data flow process. The code and corresponding documentation are stored on our github page. See:
Upcoming presentations and webinars
Building a USDM based linked repository for automation of study designs
At the start of TransCelerates Digital Data Flow project, one of the ideas was to enable automatic study builds based on the selection of objectives and endpoints. Now that the study design model, USDM v4.0, is available, we are able to do this. And of course, in combination with AI, we can do this even better.
During this Break & Learn webinar, we will dive into this use case; what information is needed, how can we reuse the USDM structure to build a repository and how could that work in practice in a solution. Feel free to sign up for this webinar and listen in directly or get the recording afterwards.
The Clinical Data Science Conference – PHUSE US Connect 2026
Join the global clinical data science community in Austin for a week of innovation, collaboration, and hands-on learning. PHUSE US Connect 2026 offers fresh perspectives on topics like AI in clinical trials, data automation, and regulatory insights.
For this year’s edition Berber Snoeijer will be presenting “The Revolution of Digitized Study Designs: Standards, Use Cases and Tools.” In addition, she will also serve as Chair of the RWE Pavilion.
Click for more information about this must-attend event for anyone in clinical research and data science.
2026 CDISC Europe Interchange
Berber Snoeijer will be delivering a two-day advanced training “Understanding USDM: Digital Design and Schedule of Activities” at the CDISC Europe Interchange 2026 in Milan.
She will also be presenting “Building a library of instantiated biomedical concepts to ensure consistency and reusability in study designs”.
Click for more information about the CDISC Europe Interchange 2026.
Chairing Real World Evidence working group
Member
EU Connect conference committee: Real World Evidence
USDM development team lead and technical expert