Digitalized Clinical Development

Nurocor’s products combine to enable Digitalized Clinical Development. Digitalized 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 Nurocor Clinical Platform (NCP) provides a broad range of functional capabilities supporting key data standards, and clinical lifecycle activities and processes. NCP 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

Modularity and flexibility are achieved using microservices, supporting multiple programming languages, offering multiple data persistence platforms, being API-driven, offering a common user interface (UI) framework, and being independent of cloud platform provider.

Openness and Pluggability

NCP supports loosely-coupled integration using APIs with an internal platform integration through shared utility microservices and UI components.

Scalability, Resilience and Security

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

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Integration

All NCP APIs externalized using the API gateway are available for partner and customer integration. Software providers such as Accenture and eClinical Solutions 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.

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.

CAPABILITIES

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Application Access

  • Improves productivity.
  • Business-specific applications present content to the user in a familiar format.
  • A comprehensive central workflow engine connects the applications.
  • UI design ensures all applications have the same look and feel and common functionality.
  • Work items from all applications are surfaced to the user through 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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Digitalized Clinical Development

  • Harmonizing people, process, and technology.
  • Drives creation of the Schedule of Activities (SOA) table in the protocol from standards in the Metadata Repository (MDR). Therefore, the protocol can never be out of sync with downstream data standards.
  • Improves velocity and accuracy of trial data.
  • Accelerates the time to approval of investigational products.
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Reduce Patient Burden

  • Takes advantage of best practice trial design that takes into account 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™. It shortens the clinical trial life cycle by controlling the critical path and by streamlining and automating downstream processes from protocol authoring to submission.


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

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.

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 through multiple standard import and export formats; for example, tab-delimited text, ODM, and Define.xml; or build custom importers and exporters.
  • Programmatically exchange and use content through APIs.

Agile Standards Development

  • Takes advantage of a library of indication reference standards and adapt to specific study requirements. The reference library provides 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 through graphical representations 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

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

Controlled Terminology App

  • The Controlled Terminology application helps companies keep up to date with the quarterly releases of CDISC Controlled Terminology. The Controlled Terminology application identifies the changes between terminology releases and checks whether any terms added to an extensible codelist matches a term in the latest CDISC CT. The Controlled Terminology application 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 Digitalized Clinical Development can help you, please browse our Resources or Contact Us.

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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 required for clinical development.

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