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
Targeted validation of study designs in USDM format
This short break & learn webinar explores the practical application of the CDISC Open Rules Engine (CORE) as the definitive framework for USDM validation.
In addition, we will dive into Rule Grouping Strategies: show how to strategically categorize, and group validation rules to isolate and check areas of the USDM that relate to specific use cases like feasibility checking, schedule of activities, and document content.
Feel free to sign up for this Break & Learn webinar and listen in directly or get the recording afterwards.
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.
PHUSE Real World Data Autumn Event
We’re proud to share that ClinLine is actively involved in the Real World Evidence Working Group Leads for the upcoming PHUSE Real World Data Autumn Event 2026.
This multi-day virtual event, taking place from 30 September to 1 October 2026, brings together global experts to explore the latest developments in real-world data (RWD) and evidence generation. The program will highlight key topics such as the use of NLP and AI in RWE, digital endpoints, data lineage and provenance, and effective vendor–sponsor collaboration.
The event offers a valuable opportunity to connect with peers across the PHUSE community and contribute to shaping the future of real-world evidence.
Chairing Real World Evidence working group
Member
EU Connect conference committee: Real World Evidence
USDM development team lead and technical expert