Break & Learn
30-minute webinars
Break away from your daily activities and Learn something new in 30 minutes. During the Break & Learn webinars, content-knowledgeable presenters will share their insights in a particular topic. The planned webinars are listed below and we will add more in the coming months. The webinars are free to attend. In addition, the link to the recording will be send within 1 week after the webinar. Feel free to register and share this site with others.
Note: If you did not get a confirmation page and/or E-mail after you registered, please send us an E-mail via info@clinline.eu and we will send you the invite directly.
Building a USDM based linked repository for automation of study designs
Live webinar planned for 11th of February 2026 at 8:30 ET / 14:30 CET
At the start of TransCelerates Digital Data Flow project, one of the ideas was to enable automatic study builds based on the selection of objectives and endpoints. Now that the study design model, USDM v4.0, is available, we are able to do this. And of course, in combination with AI, we can do this even better.
During this Break & Learn webinar, we will dive into this use case; what information is needed, how can we reuse the USDM structure to build a repository and how could that work in practice in a solution. Feel free to sign up for this webinar and listen in directly or get the recording afterwards.
From Study Design to SDTM Trial Design Datasets:
using the USDM to optimize the Data Flow
Recorded on 10th of December 2025
By creating SDTM trial design datasets using study design information in USDM format, the data flow in clinical trials can be optimized and the often cumbersome and manual task of interpreting textual design aspects as described in clinical protocols can be limited. This approach streamlines the process by aligning trial design elements stored in the Unified Study Definition Model (USDM) with SDTM standards, enhancing data quality and consistency. This method promotes efficiency and supports the generation of submission-ready datasets for regulatory purposes, ultimately enhancing the overall conduct of clinical trials.
During the presentation, we will show you how trial design elements are stored in the USDM, how they can be reused for the purpose of creating the SDTM trial design datasets and how this process can be automated.
Assessing Study Feasibility Using Real-World Data Sources: A Parameterized USDM Approach
Recorded on 10 September 2025
Evaluating the feasibility of clinical studies is a critical early step in trial planning, often limited by reliance on existing data or expert judgment. This presentation explores a novel approach that leverages real-world data (RWD) sources—such as electronic health records and claims data—to assess study feasibility by parameterizing eligibility criteria.
By transforming complex inclusion and exclusion conditions into structured, computable parameters, we demonstrate how to assess eligible patient populations within real-world datasets. We will show how USDM syntax template capabilities and timeline capabilities aid the automation of these assessments. This supports protocol refinement with the aim to reduce clinical trial costs considerably and informs optimized recruitment strategies.
We will touch upon ongoing initiatives in Eligibility Criteria parameterization and will link our efforts to ongoing CDISC 360i initiatives.
Mastering the Jungle of Real-World Data
Recorded on 2 April 2025
Real-World Data (RWD) is increasingly used in regulatory submissions within the healthcare and pharmaceutical industries. Although as an industry we see that the value of this data may be huge for improved insights and decreased timelines in the development of new drugs, many attempts in efficiently utilizing real-world data for regulatory submissions seem to fail due to the data complexity and the unfamiliarity with this data and its features.
During this 30-minute presentation Berber Snoeijer of ClinLine and Jules van der Zalm of OCS Consulting will handle a number of issues related to real-world data utilization for regulatory purposes and show you how we enable the data lineage from real-world data source to submission ready datasets as well as how we take care of additional information needed for traceability and trust in the data.
Don’t miss this unique opportunity to ask questions to our specialists during this live session.
Unravelling the Secrets of Data Lineage
Recorded on 5 February 2025
In this 30-minute Break & Learn webinar, we will dive deep into the concept of data lineage, exploring what it is, why it matters, and how new technologies are enabling organizations to track and govern their data like never before. We will explore some key questions like:
– What is data lineage?
– What information is needed to achieve data lineage?
– How can new technology enable data lineage?
During the webinar, we will walk through various examples of data lineage solutions in practical scenarios.
Using Parameterized Eligibility Criteria for Assessing Clinical Study Feasibility
Recorded on 22 May 2024
Eligibility Criteria are defining what patients are included in a study. The more strict the population is defined the higher the chance that a potential effect can be proven. However, the more strict the eligibility criteria are, the higher the chance that the study is delayed or needs to be amended due to patient recruitment issues. Moreover, the population that is included in the study with a strictly defined population might only reflect a small part of the real patient population that is intended to use the medication after registration.
Assessing the study feasibility based on eligibility criteria will give insights into the actual patients that meet the criteria and the difference with the overall patient population and thus the potential limitations and biases a study might have. It is key to have these insights fast at the study design phase to not further delay the clinical study process and thus the availability of crucial medication for patients. Smart eligibility criteria digitalization according to CDISC USDM principles will aid these fast insights and readily can show how changes in the definitions have an impact in recruitment and representatives.
During the Break & Learn webinar we will show you how criteria can be digitized and how it can be taken further to give the insights we need using our Open Tool Solution.
Strengths and limitations of Real-World Data
Recorded on 25 September 2024
Real-world data sources are increasingly used for clinical trials. Not only for feasibility assessments, patient selection and follow-up, but also for regulatory submission purposes. The requirements for using real-world data vary depending on the use case.
In this 30-minute webinar, we will look into the strengths and limitations of real-world data; where does the data come from; how is it collected and what are the corresponding caveats and biases? Correspondingly, we will discuss how we can overcome these issues and what needs to be included when assessing feasibility of a data source that are intended to be used for regulatory submission purposes.
Experiences in Real-World Data Mapping
Recorded on 15 March 2024
More and more clinical studies for regulatory purposes include real-world data to substantiate safety and/or efficacy claims. Apart from the direct clinical data needed to for safety or efficacy claims, the inclusion of metadata is crucial to account for provenance, representativeness, and data quality concerns a regulator may pose. This requirement is articulated in the FDA guideline ‘Considerations for the Use of Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’ (August 2023) and the EMA Data Quality Framework for EU medicines Regulation (October 2023). Data originating from real-world data sources comes in many different formats with varying documentation. Thorough mapping of this data is essential to structure the information for regulatory purposes and gain a comprehensive overview of usable data for clinical studies.
In this 30-minute Break&Learn webinar, led by Berber Snoeijer from ClinLine and Lieke Gijsbers from OCS Life Sciences, we will delve into our experiences and share best practices for effectively handling and mapping real-world data, ensuring their suitability for regulatory purposes.
A Dive Into the World of Biomedical Concepts
Recorded on 31 January 2024
What are biomedical concepts and how can we practically use them? During this presentation Berber Snoeijer will dive into the aspects and use of biomedical concepts from various dictionaries. This includes OMOP, CDISC standards and more. Biomedical concepts can be used in our own clinical trial practices and to get access to data from external real-world data sources. One of the difficulties is the linkage (or mapping) of biomedical concepts from one dictionary to another. Berber will explain the issues and how to overcome them.
This presentation was well received during the PHUSE EU Connect conference in November 2023. Participants liked the clarity and overview and got a better understanding of Biomedical Concepts from it.
Breaking down the silos using the digital data flow
Recorded on 6 December 2023
Have you ever considered where the digital data flow of a clinical study nowadays starts and where it could start? Actually, information generation for a clinical study starts with the drug development planning phase, where we define what studies to perform and how. We start with a study’s main design concepts: objectives, endpoints, indication, interventions, blinding, and more. Once the protocol is written, more details are added and the full study path is laid out. Thereafter, additional operational aspects and data collection details are added to the data flow. All of this put together, already a lot of design and meta information is available before the start of the actual study.
Nowadays, this pre-study information is mainly stored as text and fragmented pieces of information in documents and unlinked databases. What if all this data was digitized and linked? Would it be possible to work together on one single combined data source without the risk of compromising each other’s work?
In this 30-minute Break & Learn session on 06 December, Berber Snoeijer will demonstrate how the recently published CDISC USDM data model* can help store this information in a standardized data structure, how this can inform downstream processes and how different departments can work together on the same linked data source. Achilleas Zaras from eClinical solutions will share some examples of the latter using the elluminate data platform and different user solutions.
* The CDISC USDM data model is developed in cooperation with the TransCelerate Digital Data Flow initiative.
Stakeholder commitment: The key to innovation success in clinical research
Recorded on 11 October 2023
The pharmaceutical industry is rapidly changing. Old siloed approaches of doing research are replaced by new integrated solutions and processes. In addition, new and diverse data sources are emerging which need to be integrated and standards adoption and efficiency is becoming more and more important in a (semi-) automated data pipeline.
To make each change successful, we not only need to look at technical and procedural solutions but also at the people who have to implement and/or use them. Who are these stakeholders? Are they supportive and well informed? The experience is that when they are not, this can cause huge delays or even failure of an implementation or change project.
During this 30-minute break & learn session, Berber Snoeijer and Kemi Olutunbi will dive into commonly occurring stakeholder issues from their experience. This includes stakeholder identification, stakeholder profiles and concerns and stakeholder communication strategies.
Reducing the validation burden of clinical reporting
Recorded on 22 February 2023
Validation of clinical report content such as tables, listings and figures (TLFs) is a considerable burden in the clinical trial process. This includes validation of output formats, cross-checks with specifications and between tables, and double programming of output statistics. In this 30-minute Break & Learn session, we will dive into the reasons why this extensive validation is needed and we will discuss potential solutions for reducing the burden. The webinar will end with an automated validation use case by Beaconcure and additional time for questions and comments.