TransCelerate DDF Submission

Confidential

All content on this page is confidential and Nurocor Intellectual Property. The content is provided for evaluation purposes solely for the TransCelerate BioPharma Digitial Data Flow Hackathon and Sanofi RFI

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Introduction

The Nurocor Clinical Platform (NCP), the Lean Protocol™ Process, and an introduction to the Nurocor MDR and Vision UI.

Navigation

An orientation to the navigation capabilities, the UX experience, and the suite of applications in the NCP that support the TCB protocol and study design requirements.

Reference Libraries

The Nurocor approach to satisfying the DDF Reference Library requirements for managing Study Design Elements. The NCP contains an embedded ISO 11179 MDR with a comprehensive model supporting protocol and study design metadata including the Study Design Elements defined by the DDF Common Data Model.

Study Build

A look at how Study Design Elements are used in the NCP suite of connected applications to realize a standards driven digital data flow from Indication related Objectives and Endpoints to Biomedical Concepts and the Schedule of Activities.

Reporting and Exports

A first look at GraphQL and how it drives federated API based access to the NCP, in particular to support reporting and analytics capabilities.

UX Designs

An overview of UX designs for future Apps to be included in the NCP:

  • Visual Study Designer
  • Protocol Authoring
  • Reference Library Editor

Technology

An overview of the NCP technical and solution architecture, including a review of the MDR-based metamodel in support of DDF Common Data Model, a discussion on the use and benefits of GraphQL in NCP and a walkthrough of NCP’s UI integration framework.

Conclusion

How well has Nurocor satisfied the requirements of the DDF Hackathon, what can be improved, and an outlook on Nurocor’s commitment to further develop solutions that support digital clinical development.

Nurocor has deployed the NCP instance used in preparing its submission videos in a hosted AWS environment. We will maintain this environment during the DDF submission and judging period for access by TransCelerate team members. Because NCP applications are dynamically configured via MDR-managed content (i.e., Nurocor’s implementation of the TransCelerate Common Data Model), we have established guest user credentials that restrict Vision access to read-only mode to ensure that important configuration properties are not inadvertently altered. 

Nurocor Clinical Platform (NCP)

As part of its mission to bring order to clinical data, Nurocor has developed the Nurocor Clinical Platform (NCP). The NCP provides a broad range of functional capabilities supporting key Data Standards, Clinical Lifecycle activities, and processes; and is built to be future proof based on state-of-the-art architecture and leading open source technologies. This combined approach delivers a full set of shared technical capabilities based on three core principles:
• Modularity and flexibility
• Scalability, resiliency and security
• Openness and pluggability

This white paper explores each core principle in turn, elaborating on key aspects of the NCP and what each delivers to customers and partners.

Need More Info

For more information about Nurocor, and how Digitalized Clinical Development can help you, please browse our Resources or Contact Us.

Need More Info

For more information about Nurocor, and how Digitalized Clinical Development can help you, please browse our Resources or Contact Us.

Nurocor

Nurocor provides the industry-leading platform for Digitalized clinical development to help companies bring drugs to market faster. Automating the Nurocor Lean Protocol™ with the Nurocor Clinical Platform delivers a front-loaded, workflow-driven, digital process enabling the parallelization of multiple steps to significantly reduce the time taken in clinical development.

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