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.

Dedicated to optimizing efficiency in the clinical data flow
+ Reduce costs for drug and device development
+ Optimize opportunities for patients and health care professionals
Combining technical skillsets with content knowledge and business process insights and experience
+ Driving innovative processes
+ Keeping the big picture
Involved in industry-wide improvement processes like
+ TransCelerate / CDISC Digital Data Flow Initiative
+ Chair Real-World Evidence working group PHUSE

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:

USDM v4.0 to SDTM trial design domain mapper

Mapping Lineage Visualization Tool

Upcoming presentations and webinars

Join EUCROF for her 9th Annual Conference

Building on the momentum of nearly 350 attendees at EUCROF25, EUCROF26 will once again bring together clinical research professionals from across Europe and beyond. Expect three days of high-impact networking, thought-provoking sessions, and future-focused dialogue designed to accelerate innovation and excellence in our field.

Join us from 1–3 February 2026 as we shape the next chapter of clinical research; together.

At this conference ClinLine will present: “The Revolution of Digitized Study Designs: Standards, Use cases and Tools”

Visit the website for more details around the conference.

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, whe 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

ClinLine will be delivering a two-day advanced training workshop “Understanding USDM: Digital Design and Schedule of Activities” at the CDISC Europe Interchange 2026 in Milan.

SDTM Advanced + Hands-On Implementation is an instructor-led course that combines advanced SDTM theory with practical, hands-on exercises. During this immersive training, participants will deepen their understanding of complex SDTM concepts, including CRF annotation, traceability, metadata submission guidelines, and SDTM conformance validation using the CDISC Open Rules Engine (CORE).

Through interactive group activities and real-world, project-based exercises, attendees will gain practical skills to confidently apply SDTM standards in clinical studies. 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