Compliance

Ensure Compliance with Regulatory and Industry Standards

  • Manage all data standards (Clinical, Non-clinical, PGx) used across the entire R&D enterprise in one central location.
  • Improve data integrity by using CDISC data standards, throughout the clinical lifecycle, from study protocol through to final submission data sets and artifacts.
  • Automate governance processes to ensure that approved data standards are used consistently across the entire study portfolio, to meet regulatory (FDA, PMDA) requirements.
  • Guarantee traceability and authenticity of data from collection, through to final use in a clinical report or submission data set, as required by regulatory bodies.
  • Manage multiple active versions concurrently to facilitate individual submission needs and clearly document data provenance from point of collection to final usage.

The Solution: Nurocor MDR

Reusability

Reuse data assets to improve productivity, quality and efficiency

  • A strong metadata management tool is the primary enabler of an organization’s digital data strategy.
  • Maximize the value clinical trial data. The use of robust and consistent data standards, across the entire study portfolio, enables study data to be used beyond its original purpose, accelerating business development.
  • “Define once, use many times”, ensure that data definitions are consistent and utilized across multiple systems.
  • Simultaneous use of any version, of any standard, at any time.
  • Deliver a hierarchy of standards (global, product, therapeutic area and study) that allows reuse or specialization at any level in the hierarchy.
  • Support any standard including specialized standards including, medical devices and pharmacogenomics
  • Reduce costly delays by ensuring personnel across the clinical development organization (or in academic research) utilize and share the same data terminology, regardless of functional area, with partners, vendors & CROs.
  • Eliminate reliance on spreadsheets for “primitive” metadata management.
  • Simplify data aggregation and meta-analysis across multiple clinical trials.
  • Improve the fidelity of clinical trial simulations using accurate and consistent data.

The Solution: Nurocor MDR

Automation

Automate routine data processes to reduce manual effort and errors

  • Focus specialized personnel on high value tasks while automating the routine and repeatable.
  • Make smarter decisions with increased confidence during the conduct of clinical trials.
  • Reduce time to implement rich data visualization and standard reports
  • Reduce costs and improve operational efficiency by eliminating unnecessary clinical and statistical programming tasks and reusing standardized and validated transformation algorithms and code.

The Solution: Nurocor MDR

Nurocor MDR™

Nurocor MDR™ is a high-performance, enterprise-class software platform that helps BioPharma organizations meet objectives for standards development and implementation. The platform facilitates a collaborative, metadata-driven information lifecycle with a centralized, standards-based metadata repository and governance process automation. Enterprises can use predefined governance processes based on industry best practices or can easily define their own custom governance processes via a drag and drop process editor.

  • Governance
  • Workflow
  • Versioning
  • Creation/Maintenance
  • Import/Export

PRODUCT INFO

Nurocor Approach

Semantics Manager provides metadata management for an end-to-end data lifecycle – including public or private standards and data exchange formats – which can be any established norm or requirement with a formal document that establishes uniform engineering or technical criteria, methods, processes, and practices. Semantics Manager provides an authoritative source and governance for creation of standards and metadata, as well as automatic inheritance and impact analysis of any proposed changes.

User Interface

  • Browser based UI for creating and viewing metadata content
  • Eclipse UI for configuration

User Management

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

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

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

Other

  • Multiple import and export formats
  • Ability to link or integrate with external information sources (e.g. terminology services, master data management tools, source systems, etc.)
  • Extensive reporting capabilities
  • Collaboration capabilities at all levels
  • Impact analysis and inheritance
  • Repository federation

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.