Digitized Clinical Development

Nurocor’s products combine to enable Digitized Clinical Development. Digitized Clinical Development provides a way to bring drugs to market more quickly by shortening the clinical process and simultaneously making it more accurate to ensure right-first-time regulatory submissions.

Nurocor Clinical Platform

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

Using microservices, supporting multiple programming languages, offering multiple data persistence platforms, being API-driven, offering a common UI framework, and being independent of cloud platform provider.

Openness and Pluggability

Supporting loosely coupled integration via APIs, with an internal platform integration via shared utility microservices and UI components.

Validated System Status

NCP has achieved validated system status under CFR 21 Part 11 ensuring that clinical study practitioners get the accurate and complete results they need as they work to deliver new medical treatments to the public.

Scalability, Resilience and Security

Built on a Docker/Kubernetes deployment backbone, supporting synchronous and asynchronous communications, using a secure API perimeter, with pluggable authentication, and modern platform administration tools.

Integration

All NCP APIs externalized via the API Gateway are available for partner and customer integration. Software providers such as Accenture and eClinical Solutions currently take advantage of this ready access to NCP content, and many Nurocor customers also implement special-purpose utilities using these APIs (including SQL read-only data views where available).

CAPABILITIES

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Application Access

  • Improve productivity
  • Business specific Apps present content to the user in a familiar format
  • A comprehensive central workflow engine connects the Apps
  • UI design ensures all Apps have the same look and feel and common functionality
  • Work items from all Apps surfaced to the User via a single Dashboard
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User Management

  • Standard and custom roles assigned to users
  • Multilevel user groups
  • User profiles associated with UI views
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Digitized Clinical Development

  • Harmonize people, process & technology
  • Drive creation of the Schedule of Activities (SOA) table, in the protocol, from standards in the MDR and the Protocol can never be out of sync with downstream data standards
  • Improve velocity and accuracy of trial data
  • Accelerate the time to approval of investigational products
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Reduce Patient Burden

  • Take advantage of best practice trial design that takes into accounts overall patient burden
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Reporting & Visualization

  • Impact analysis
  • Traceability
  • Annotated CRF
  • Define.xml
  • Metrics
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Content Management

  • Configurable content meta model
  • Configurable data entry forms based on role, metadata content, and the state of the content
  • Ability to apply business rules
  • Multiple search capabilities
  • Dynamic relationship views
  • Full audit trail
  • Automated version control
  • Ability to create model templates that can be used to create and constrain content
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Workflow Management

  • Configurable governance workflows
  • Ability to govern content creation by individual assets or in batches by content type
  • Workflow configuration supports multiple parallel and/or sequential reviewer steps
  • Ability to govern the consumption of content

Lean Protocol™

Lean Protocol

The Lean Protocol™ process is an end-to-end approach to front load and parallelize clinical trial processes based on a collaborative environment for developing digital study protocols. Standards driven digital protocol development is essential to Lean Protocol™, shortening the clinical trial life cycle by both controlling the critical path and by streamlining and automating downstream processes from protocol authoring to submission.

The Lean Protocol™ process is based on a gated protocol workflow, configurable by sponsors using Nurocor’s digital protocol platform. In a gated protocol workflow, pre-defined gates with well-defined quality control criteria decide when meaningful parts of a protocol can be locked down. Once locked down, depending clinical trial processes can be started before the full protocol reaches final status. These processes can be manual or automated.

The early start of clinical trial processes such as study planning, feasibility, recruitment, and others can significantly shorten time to First Patient First Visit (FPFV), thus reducing overall time to submission.

Other benefits of a Lean Protocol™ process enabled by a standards driven digital protocol platform include the following:

  • Consistent study design optimization from CDP to clinical trial execution
  • Optimized study schedule with reduced patient burden and increased standard of care
  • Early study design verification, resulting in reduced protocol amendments
  • Up front standards compliance by design
  • Increased integration and automation across clinical trial systems

Metadata Repository (MDR)

Address Clinical Development Challenges

  • Create, maintain, govern and use standards in a consistent manner
  • Know the impact of changes on other people, processes, or systems
  • Get maximum reuse out of existing data assets
  • Implement standards to improve processes
  • Minimize human intervention and interpretation when exchanging data

Create, Manage and Govern Content

  • Build content based on standards and/or standards-based templates (base library includes CDISC Terminologies, CDASH, SDTM, BRIDG, and associated data types).
  • Create content within context or as individual objects, including mapping and transformation logic
  • Define validations to enforce business rules & policies
  • Govern the creation and/or consumption of content, notifying the appropriate stakeholders throughout the process

Easily Find, Use, Share & Integrate Content

  • Navigate content through configurable tree structures, interactive reference models, or customizable searches
  • Federate to other internal/external installations of Nurocor MDR (including partners and SDOs).
  • Import/export content from the UI via multiple standard import & export formats (e.g., tab-delimited text, ODM, Define.xml) or build custom importers and exporters
  • Programmatically exchange and use content via APIs

Agile Standards Development

  • Take advantage of a library of indication reference standards and adapt to specific study requirements. The reference library can provide a starting point for the development of a new indication standard reusing as much existing content as possible and augmenting as necessary.

Analyze Impact of changes to Content

  • Understand relationships via graphical representation or automated
  • Inform governance stakeholders of the impact of changes
  • Auto-assign tasks for stewards to indicate whether or not to inherit

Analyze and Monitor

  • Take advantage of integrated open source reporting tools
  • View prebuilt and develop custom fully parameterized reports
  • Use the provided reporting views to build reports using any SQL-aware reporting tools
  • Surface reports dynamically within or external to repository
    Share reports via multiple report export formats

Controlled Terminology App

  • The CT App helps companies keep up to date with the quarterly releases of CDISC Controlled Terminology. The App identifies the changes between terminology releases and checks whether any terms added to an extensible codelist match to a term now found in the latest CDISC CT. The CT App helps users determine which terms to import into the repository to provide a complete terminology package based on the latest release.

Solution Delivery

Our platform is available as a hosted cloud service, on premise installation or managed service in a Virtual Private Cloud. Nurocor will work with clients to provide the optimal solution to meet their needs.

Need More Info

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

Need More Info

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

Nurocor

Nurocor provides the industry-leading platform for digitized 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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