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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:

Clinical LifeCycle Suite

The Clinical Lifecycle Suite is the collective term for the Nurocor Clinical Platform apps supporting standards-driven protocol development. The Clinical Lifecycle Suite achieves the goal of the Digital Data Flow architecture as articulated by TransCelerate. A digitalized clinical development process is a prerequisite to achieve a high level of automation with the key data fabric principle of automated decision making. This suite includes Study Designer, Study and Protocol Elements, Schedule of Activities, and Authoring.

NCP Dashboard:

The Nurocor Clinical Platform (NCP) Dashboard is the central location for accessing information within the platform. The display and the tabs on the dashboard may vary depending upon your user role and permissions within the system and the applications available in the platform. After logging in to the platform, the Dashboard displays a list of studies that are present in the system. Note that some or all of the studies in the system may not be visible to you, based on the roles and properties assigned to your user profile.

Study Designer Platform:

The Nurocor Study Designer enables you to create your study design from the ground up.  Using Study Designer, you can create:

  • Trial elements
  • Study schematics
  • Arms views
  • Trial arms datasets

Study Designer keeps your study design in one centralized location, and enables you to maintain and update the study design as required.  Study Designer is integrated with Nurocor’s Study and Protocol Elements and Schedule of Activities apps.

Additionally, you can export your data for submission to the U.S Food and Drug Administration (FDA).  

Study and Protocol Elements:

The Nurocor Study and Protocol Elements app is designed to turn your study’s text documents into a structured part of your Nurocor Clinical Platform (NCP) solution.  Using the Study and Protocol Elements app, you can easily create, modify, and maintain your study purposes, objectives, and endpoints in an application environment connected to the Nurocor Metadata Repository (MDR) and Nurocor Vision.  

Schedule of Activities:

The Nurocor Schedule of Activities (SOA) app is a component of the Nurocor Clinical Lifecycle Suite.  SOA guides study designers through an intuitive process of schedule specifications. Starting with defined activities sourced from the Nurocor Clinical Platform (NCP) to generate study events and planned activities within the schedule, SOA enables you to efficiently produce a full-fidelity set of schedules in support of a study.  In other words, SOA is sufficiently detailed to generate a casebook that can in turn produce an electronic data capture (EDC) build, as well as be used to produce  Study Data Tabulation Model (SDTM) study specifications by mapping rules within the standards.  These schedules are then propagated back to the Nurocor MDR for purposes of downstream (EDC), study build automation and/or non-case report form (CRF) data specifications.

Clinical Standards Suite

The functional foundation of the Nurocor Clinical Platform is the Nurocor Metadata Repository (MDR). The MDR, in combination with the Vision Nurocor Clinical Platform application, supports the definition, review, approval, and provisioning of industry-defined and customer-specific clinical lifecycle standards. These standards include data standards spanning the clinical lifecycle (collection, tabulation, and analysis), and standards in support of clinical study artifacts such as protocol and SAP documents, objectives and endpoints, and full-fidelity schedule of activities definitions. This suite includes Metadata Repository, Vision, and Controlled Terminology Importer.

Metadata Repository:

The Nurocor Metadata Repository manages your standards and metadata throughout the R&D data lifecycle.

Vision:

Vision™ is a web-based application that runs on the Nurocor Clinical Platform™ (NCP), enabling you to intuitively view your Nurocor Metadata Repository (MDR). The MDR consists of a library of content specific to your company and your work. Vision provides you with convenient ways of viewing and working with your relevant information. Items stored in your MDR and the information relevant to each are categorized to make them easy to locate. You can use these categories to navigate through the MDR and to filter and organize your information. Additionally, relationships between various types of content are depicted to illustrate associations and support meaningful navigation through the MDR.

Controlled Terminology Importer:

Keeping your controlled terminology up-to-date can be a daunting task. The Nurocor Controlled Terminology Importer (CTI) simplifies this task by importing new controlled terminology in the National Cancer Institute (NCI) format and incorporating those changes into the Nurocor Metadata Repository (MDR) library.

The Clinical Data Interchange Standards Consortium (CDISC) issues quarterly release updates. CDISC terminology files are always cumulative, so you can import new terminology files at your own pace, but need to do so at most once per quarter if you want to always have the latest version. Your terminology may contain sponsor extensions to cover terms not previously defined by CDISC. Note that CDISC terms always have a C-code which is an identifier starting with the letter C and followed by a five- or six-digit code. Sponsor extensions do not have a C-code. Importing a new CDISC terminology file may contain new CDISC terms that need disambiguation in the presence of existing sponsor extensions; otherwise this could result in the creation of duplicate terms. The CTI identifies potential duplicates and what has changed, so you can easily determine the changes to accept or reject in your terminology.

Study Workbench

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Study Data Tabulation Model Generator:

The Study Data Tabulation Model (SDTM) Generator utilizes the conceptual model for transformations and mapping between lifecycle stage standards to automate the creation of SDTM datasets. The mapping and transformation logic stored in the MDR is transformed into executable code (SAS, R, and others) and handed over to your statistical computing environment (SCE) through system integration.

ADaM Generator:

The Analysis Data Model (ADaM) Generator utilizes the conceptual model for transformations and mapping between lifecycle-stage standards to automate the creation of ADaM datasets. The mapping and transformation logic stored in the MDR is transformed into executable code (SAS, R, and others) and handed over to your statistical computing environment (SCE) through system integration. 

Tables, Figures, and Listings Generator:

TFL Specification – The Tables, Figures, and Listings (TFL) Specification app enables a study statistician to configure the TFL requirements for a study from the TFL reference library stored in the MDR.

Platform Capabilities

The following applications are currently in development and will be available soon.

 

Structured Authoring:

Authoring app – A generic authoring microservice that can be driven from authoring templates; for example, Protocol, SAP, and CSR.  Auth integrates with the structured model and shares content created by other NCP apps.

Clinical Development Plan:

The Clinical Development Plan is a component targeted at supporting the decision and design processes related to the creation of the clinical development plan (CDP), the target product profile (TPP), optimized program and study designs, and the protocol synopsis.

Lean Protocol™ :

Is a gated workflow process that structures a clinical study protocol as a sequence of stages, with each stage specifying a logical grouping of study development tasks. It enables previously serial processes to run in parallel. 

Report:

The built-in reporting engine provides a facility for configuring reports of Nurocor Clinical Platform (NCP) content utilizing the native NCP APIs.

The Nurocor mission is to bring order to clinical data.  The world of clinical data is becoming increasingly complex.  We believe that through disciplined management of data standards and semantics, we can control this complexity, and turn it into a business advantage.

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