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
From Biomedical Concepts to the Schedule of Activities: Building a Reusable Study Design in USDM
Join us on 23 September for a 30-minute Break & Learn webinar exploring how CDISC Biomedical Concepts and the Unified Study Definitions Model (USDM) can bring structure and reusability to the Schedule of Activities (SoA). Using a practical example, we’ll show how an instantiated Biomedical Concept from a company library can be built into a USDM-formatted study design — linked to activities, scheduled across encounters and epochs, and validated for completeness and consistency.
We’ll also touch on how a computable SoA can support downstream automation, including EDC configuration, data-transfer specifications, SDTM dataset creation, and Define.xml.
Plus a preview of ClinLine’s participation in PHUSE EU Connect in Glasgow this November, where we’ll present on the pathway from the Schedule of Activities to Define.xml and the Biomedical Concept journey.
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. The event offers a valuable opportunity to connect with peers across the PHUSE community and contribute to shaping the future of real-world evidence.
We will be involved in 2 presentations:
- “Assessing Quality and Usability of Real-World Data Sources”, Berber Snoeijer, ClinLine
- “From Criteria to Connection: Enabling Diverse Participation with USDM through READI”, John Owen, CDISC and Berber Snoeijer, ClinLine
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.
PHUSE Single Day Event, Copenhagen
On 22 October, ClinLine will be presenting at the PHUSE Single Day Event in Copenhagen, hosted by Ferring Pharmaceuticals. This year’s event is themed “Better, Faster, Smarter: Clinical Data Science in Practice,” bringing together clinical data scientists and statistical programmers to explore practical, hands-on solutions for everyday challenges in SDTM/ADaM/TFL development and automation. phuse
We’ll present “From USDM to SDTM: Creating Trial Design Domains at the Push of a Button,” demonstrating how a structured, USDM-based study design can be translated directly into SDTM Trial Design domains — turning a traditionally manual, time-consuming process into a fast, repeatable, and consistent one.
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.” She will also give the presentation “Walking the BC journey: from assessment selection to submission.“
For more information about the conference, visit this link.
Missed a Webinar? Watch the Recording!
Did you miss one of our Break & Learn sessions? No worries – you can still catch up!
On the Break & Learn page you’ll find an overview of previous hosted webinars. Simply fill in your details and the recording link will be sent directly to your inbox. It’s a quick and easy way to stay informed on your own time.
Feel free to explore the topics that interest you most!
Chairing Real World Evidence working group
Member
EU Connect conference committee: Real World Evidence
USDM development team lead and technical expert