Updated: 6th September 2022

EvidentIQ joins forces with Novo Nordisk to present the Open Study Builder at the DDF connect-a-thon

2 min read By Léa Blaszczynski

We are proud to announce that EvidentIQ is joining forces with Novo Nordisk to present the Open Study Builder at the Digital Data Flow (DDF) connect-a-thon.

This DDF Initiative for the TransCelerate Connect-a-thon will take place virtually from Sept. 12 – Sept. 30, 2022 and will focus on practical ways in which how companies can use the Study Definition Repository Reference Information and CDISC’s Unified Study Definitions Model.

DDF tries to respond to current issues. There exists an average lag time of four months between protocol completion and start of study. Furthermore, third-party conversion of data to Study Data Tabulation Model (SDTM) lengthens cycle time and presents limits for traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort.

 The DDF initiative aims at modernizing clinical trials by enabling a digital workflow to allow for the automated creation of study assets and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process.

During the Stream “Supplemental Data and Additional standards”, we will show how to map the data between the DDF platform and the Open Study Builder. We will also connect the Open Study Builder with our Marvin EDC and the REDCap Cloud system.

In this context, our scope is broader than the current Unified Study Definitions Model (USDM) – and we see the main benefit, especially in relation to the EDC study setup.

 EvidentIQ can help every pharma company which needs to set up a new study builder infrastructure. In the Open Study Builder, we are writing the protocol in such a way that we automatically start creating the case report in advance as some relationships will be defined at the Library level. When we are creating a case report form in our EDC system Marvin by loading it from the Study Builder, this data is directly linked to the protocol.

 It is a Concept Based Data Standard approach process!

 Why is this important and what are the benefits:

  • Facilitate consistency of data
  • Minimize bottlenecks between processes and systems
  • Minimize manual work, data re-entry, and data inconsistencies
  • Improve clinical trial efficiency by achieving seamless information flow across multiple systems
  • Spark innovation that will generate new technologies and features, most notably interoperability and automation
  • Harmonize the protocol set of information

The idea is that the TransCelerate group facilitates creation of API based standards to put in place an electronic system to collect protocol information, in an electronic form for pharmaceutical companies to drive down stream usage.

 We are very excited about this, please contact us for more information and/or follow: Connectathon Home | Digital Data Flow (transcelerate.github.io)

When: 12th-30th September, 2022

Where: Online.

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