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 NCP provides a broad range of functional capabilities supporting key data standards and clinical lifecycles, activities, and processes.  The 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

Openness and Pluggability

Scalability, Resilience, and Security

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 apps 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 permissions assigned to your user profile.

Study Designer

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

  • Trial elements
  • Study schematics
  • Trial arms

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 (SPE) 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 and protocol elements for study design, eligibility, interventions, objectives, and endpoints in an application environment connected to the Nurocor Digital Asset Repository (DAR) 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, and a set of Study Data Tabulation Model (SDTM) specifications together with mapping specifications from collected to tabulated data. These schedules are then propagated back to the Nurocor DAR for purposes of downstream (EDC), study build automation and/or non-case report form (CRF) data specifications.

Statistical Analysis Plan

The Schedule of Activities app provides fine-grained control for defining the data to be collected in a study and uses that information for the downstream automation of the Electronic Data Capture (EDC) build and SDTM dataset creation. Similarly, the Statistical Analysis Plan (eSAP) application provides fine-grained control for defining the data to be analyzed in a study and uses that information to assist in the downstream creation of the analysis datasets and Tables, Figures, and Listings (TFL) outputs.

Clinical Standards Suite

The functional foundation of the Nurocor Clinical Platform is the Nurocor Digital Asset Repository (DAR). The DAR, 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 Statistical Analysis Plan (SAP) documents, objectives and endpoints, and full-fidelity schedule of activities definitions. This suite includes Digital Asset Repository, Vision, and Controlled Terminology Importer.

Digital Asset Repository

The Nurocor Digital Asset Repository (DAR) enables the curation, versioning, governance, publishing, and consumption of the clinical lifecycle standards, including relationships that capture lineage and traceability across the lifecycle.

Vision

Vision™ is a web-based app that runs on the Nurocor Clinical Platform™ (NCP), enabling you to intuitively view your Nurocor Digital Asset Repository (DAR). The DAR consists of a library of content specific to your company and your work. Vision provides you with convenient ways of curating, publishing, and consuming clinical lifecycle standards. Items stored in your DAR and the information relevant to each are categorized to make them easy to locate. You can use these categories to navigate through the DAR 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 DAR.

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 Digital Asset Repository (DAR) 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. The CTI tracks disambiguation of new terms in the presence of existing sponsor extensions to avoid the creation of duplicate terms. The CTI identifies potential duplicates and assists the user to accept or reject these terms.

Study Workbench

The Study workbench provides a series of apps enabling your standards to be configured for study use.

Study Data Tabulation Model Generator

The Study Data Tabulation Model (SDTM) Generator utilizes a conceptual model for transformations and maps relationships between collection and tabulation standards to automate the creation of SDTM datasets. The mapping and transformation logic stored in the DAR 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 a conceptual model for transformations and mapping relationships between tabulation and analysis standards to automate the creation of ADaM datasets. The mapping and transformation logic stored in the DAR 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 study specific TFLs from the TFL reference library stored in the DAR.

Platform Capabilities

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

 

Structured Authoring

Authoring app (Auth) – A generic authoring microservice that is template-based and model and standards driven; for example, Protocol, Statistical Analysis Plan (SAP), and Clinical Studies Report (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™

Nurocor Lean Protocol™ (LP) 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. Lean Protocol allows the study protocol version to be parallelized. In other words, Lean Protocol allows a controlled initiation of downstream tasks in phases based on sign-off of different aspects of the protocol version definitions. This enables you to get to first patient/first visit much quicker.

Report

NCP Report Service – The built-in reporting engine provides a facility for configuring reports of Nurocor Clinical Platform (NCP) content utilizing the native NCP APIs. The DAR includes a set of baseline reports that can be used as-is or modified to suit your needs. Additionally, new custom reports can be created and included in this section. Examples of these reports are:

  • Annotated CRF Report: An ECRF specification report with SDTM annotations.
  • Comparison Report: A listing of all differences between two specified metadata items.
  • Governance Monitoring Report: Lists a detailed history of completed and active approval requests and the average time to complete each type of approval.

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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