Dear ,

This year we introduced a series of 30-minute open Break & Learn webinars to share valuable knowledge. So far, we’ve conducted 7 sessions, covering topics related to clinical research optimization for the pharmaceutical industry. All webinars are recorded and available for viewing on our website. Check out the recordings for:

  • Strengths and limitations of real-world data sources for clinical trials (January 2023)
  • Reducing the validation burden of clinical reporting (February 2023)
  • Interoperability and automation: How we handle the increasing complexity of data sources (March 2023)
  • How to overcome process inefficiencies in clinical research (April 2023)
  • How to assess relevance and provenance of real-world data (May 2023)
  • Stakeholder commitment: The key to innovation success in clinical research (October 2023)
  • Breaking down the silos using the digital data flow (December 2023)

Looking ahead to 2024, we are planning new Break & Learn webinars. The first, scheduled for 31 January, will explore “A dive into the world of biomedical concepts”. This presentation was well-received during the PHUSE EU Connect conference in November, providing participants with a better understanding of biomedical concepts and their connections to different standards. To register for the upcoming webinar and access our archive, including recorded sessions, visit our website.
 
 
2024: An Exciting Year for Digital Data Flow Advancements

Over the past years, Berber Snoeijer has immersed herself in multiple projects centered around the end-to-end, or what’s commonly known as the Digital Data Flow. Her journey began with workshops in 2020, evolving through collaborations with various clients until she found herself deeply engaged in the TransCelerate Digital Data Flow project. This initiative focuses on initially capturing study design information in a digital format that allows downstream systems to consistently reuse this data. The collaboration between TransCelerate and CDISC resulted in a new data model, the Unified Study Definitions Model (USDM), capable of containing all study design information and facilitating seamless exchange between different systems through the corresponding API. This year marked the release of Version 2.

Building on this momentum, Berber transitioned to the CDISC USDM development team to contribute to Version 3. Anticipated for the first half of 2024, this version will align completely with the new ICH M11 standard and it will also serve to inform SDTM and regulatory agency registry sites, such as ct.gov. The alignment with the M11 standard positions Version 3 as a powerful candidate for industry-wide adoption.

If you're interested in delving into the details of the USDM, exploring its potential application for your company, or seeking assistance in the implementation process, please feel free to reach out to us using the contact details below.
 

Receiving this newsletter means that you are interested in us and in our services. Throughout this year, we’ve shared information on the digital data flow, real-world data utilization, and stakeholder engagement through this newsletter and our Break & Learn webinars. We’ve enjoyed doing this in collaboration with our partners and plan to continue in the coming year.

As the year comes to an end, we want to express our sincere thanks for your interest. We wish you a wonderful holiday season and a happy New Year.

 

ClinLine is dedicated to optimizing clinical research processes. Our aim is to innovate clinical research processes in order to reduce both time to market and healthcare costs.
 
We offer full services in process optimization, digitization, and Real-World Data utilization. We do this from a holistic perspective which results in the inclusion of all stakeholders, taking into account existing processes and experiences and utilization of well-known management methods.
 

ClinLine
Van der Valk Boumanweg 15
2352 JA Leiderdorp
The Netherlands
+31 (0)71 522 35 43
+31 (0)6 211 976 21
info@clinline.eu
 

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