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
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.
This year, Berber will once again co-chair the Real-World Evidence stream and contribute to the TransCelerate/CDISC workshop, “From Schedule of Activities to Define-XML: Automating the Pathway from Design to Submission.” Together with Rhonda Facile, she will also present “Walking the BC Journey: From Assessment Selection to Submission.”
For more information about the conference, visit this link.
USDM Validation Packages
Join us for ClinLine’s final Break & Learn webinar of 2026 as we reflect on the year’s highlights, lessons, and developments across digital clinical research. We will revisit key topics from the 2026 webinar series and share an early look at the focus and planned line-up for 2027.
The session will also introduce ClinLine’s range of validation services designed to support the implementation of ICH M11 and CDISC’s Unified Study Definitions Model (USDM). We will discuss how targeted validation can help organizations create complete, consistent, and trustworthy digital study designs while improving standards conformance, interoperability, and readiness for downstream automation.
This will be an interactive session, and we want to hear from you. Attendees are encouraged to bring questions and suggest topics, challenges, and use cases they would like ClinLine to address in future Break & Learn webinars.
Join us as we close out 2026, look ahead to the opportunities of 2027, and celebrate the holiday season together.
ACDM27 Oslo
From 14–16 March 2027, the Association for Clinical Data Management (ACDM) will host its annual conference in Oslo, Norway.
ClinLine will be joining ACDM27, where Rhonda Facile will present “From Valid USDM to Trustworthy Study Design: Operationalizing USDM Validation.” The presentation will explore how effective USDM validation can help ensure reliable, consistent, and trustworthy study-design information.
For more information about the conference and registration, visit this link.
PHUSE US Connect Dallas
PHUSE US Connect returns to Texas from 14–18 March 2027, this time in Dallas. The five-day conference brings together professionals from across the global healthcare data science community for inspiring sessions, interactive workshops and discussions around the latest developments in the industry.
ClinLine will once again be joining the PHUSE community to exchange knowledge, share insights and contribute to the ongoing developments in clinical data standards and digital data flow. Berber will be presenting “From Model to Trust: Practical Validation of USDM-Formatted Study Representations Using CORE”
More details about our involvement will follow.
For more information about the conference and registration, 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.
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