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
Nurocor Core comprises shared services and applications providing cross-cutting capabilities to the platform. This includes access control, user profiles, audit trail, workflow, notifications, commenting, and change requests. These shared capabilities ensure consistent behavior and functionality across NCP applications, thereby improving the end user experience and allowing Nurocor to rapidly build new functional capabilities by reusing existing core services.
Nurocor Core includes:
Nurocor Clinical Platform
Digital Asset Repository (DAR)
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.
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.
Clinical LifeCycle Suite
The Nurocor Clinical Lifecycle Suite is used by study design teams to specify the aspects of the study in a semantically well-defined and fine-grained manner. The resulting study design then becomes actionable through Lean Protocol™ gated workflows that enable incremental and parallel initiation of downstream study build processes; for example, feasibility, data management, monitoring, and statistical analysis.
The Nurocor Clinical Lifecycle Suite includes:
Nurocor Schedule of Activities
Nurocor Study Designer
Nurocor Study and Protocol Elements
Nurocor Lean Protocol
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.
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. Learn More
Clinical Standards Suite
The Nurocor Clinical Standards Suite includes:
Nurocor Controlled Terminology Importer
Nurocor Data Standards Browser
Nurocor Objective & Endpoints Templates
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.
Objective and Endpoint Templates
The Nurocor Objective and Endpoint Templates (OET) application enables you to configure structured objective and endpoint templates based on the needs and requirements of your studies. By specifying templates for these critical elements, you can improve the quality and consistency of your studies, reducing the potential for error and increasing the likelihood of successful study execution.
Data Standards Browser
The Nurocor Clinical Platform (NCP) Data Standards Browser (DSB) is designed to provide easy access to your information through a simple user interface. The DSB is guided by data collection standards and serves the same content as found in the Nurocor Metadata Repository (MDR) and Nurocor Vision.
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.
The following applications are currently in development and will be available soon.
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
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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