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:
– USDM v4.0 to SDTM trial design domain mapper
– CDISC BC to USDM repository builder
Upcoming presentations and webinars
Building a library of instantiated biomedical concepts to ensure consistency and reusability in study designs
CDISC biomedical concepts are powerful, but how do you ensure consistent, reusable configurations across studies? In this webinar, we introduce a new open-source tool that retrieves biomedical concept instantiations from the CDISC library, lets you configure them, and exports directly to USDM format. Save your spot.
CDISC Pediatrics User Network (CPUN) meeting on Wednesday, 15 July 2025, 5–6 pm CET.
Berber Snoeijer will be presenting at the CDISC Pediatrics User Network (CPUN) meeting on Wednesday, 15 July, 5–6 pm CET.
The topic is one that’s becoming increasingly relevant: how OMOP and CDISC standards work together. As more hospitals adopt the OMOP Common Data Model, understanding where these two frameworks align and where the challenges lie is essential for anyone working in clinical data, and especially in pediatric research. Interested in joining? You can register via the CPUN page.
PHUSE Real World Data Autumn Event
We’re proud to share that we are actively involved in the Real World Evidence Working Group which is organizaing the upcoming PHUSE Real World Data Autumn Event 2026.
This multi-day virtual event, 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.
CDISC US Interchange in Denver
Berber Snoeijer will be developing and presenting the following trainings at the CDISC USD Intergechange converence in Denver, CO (5–9 October) on 7 October!
USDM Implementation Handbook Training: From SoA Design to SDTM Define (9:00 AM – 1:00 PM MT)
A deep dive into the three CDISC implementation handbooks, covering business processes, user requirements, and live open-source demonstrations.
Mastering USDM Extensions: Architecture, Design, and Practical Workflows (2:00 PM – 5:00 PM MT)
A hands-on workshop on the USDM API extension mechanism; from design best practices to real-world EDC automation use cases.
EU Connect 2026 Glasgow
PHUSE EU Connect is heading to Glasgow, UK! From 15–18 November 2026, this flagship event brings together data science and healthcare professionals from around the world to share insights, explore emerging trends, and shape the future of the industry through inspiring presentations and valuable networking.
Berber will be again co-chairing the Real-World Evidence stream again this year and she will provide the TransCelerate/CDISC workshop titled: “From Schedule of Activities to define.xml: automating the pathway from design to submission.”
For more information about the conference, visit this link.
Presentations and Recordings
From PHUSE Connects to CDISC Interchanges, ClinLine regularly shares its expertise at international conferences and webinars.
Our archive features presentations, posters, recordings and white papers that highlight our work in real-world data, digital standards, and clinical innovation.
A great way to explore our past contributions and stay inspired by what’s next. Click to view our archive.
Chairing Real World Evidence working group
Member
EU Connect conference committee: Real World Evidence
USDM development team lead and technical expert