Guest Contributor: Todd Georgieff
A Day to Discover “The Art of the Possible”
with TransCelerate’s Digital Data Flow
Nurocor was recently invited to participate in the TransCelerate DDF Discovery Day in Boston, where we provided a product demonstration to numerous global pharmaceutical companies. Please see the guest blog written by Todd Georgieff – “A Day to Discover The Art of the Possible with TransCelerate’s Digital Data Flow”. Todd has been an active contributor in TransCelerate Programs for many years.
Nurocor named as a #SampleVendor in the Gartner® Hype Cycle™ for Life Science Clinical Development, 2022
We are proud to announce that Nurocor has been named a #SampleVendor in two categories of the July 2022 Gartner Hype Cycle™ for Life Science Clinical Development report: Clinical Data Analytics Platforms and Structured Content and Component Authoring. We believe this is a powerful step forward in our work toward building the leading digitalized clinical development solution.
What is Digitalization?
Each Phase 3 Study:
What is Digitalization?
Each Phase 3 Study:
Want to know more about DIGITALIZATION?
Turn Digital Transformation into Accelerated Clinical Development with Nurocor Clinical Platform.
Digitalization – Nurocor will take you there.
Nurocor Clinical Platform provides a broad range of functional capabilities supporting key data standards, clinical lifecycle activities, and processes. Nurocor Clinical Platform is built for the future. By leveraging a state-of-the-art microservice architecture, you can take advantage of the applications important to you on a planned and structured schedule at your own pace. This results in a continuing and growing return on your investment in the platform.
Scroll over each icon to learn more about each application or feature.
Digital Asset Repository
The Nurocor Digital Asset Repository manages your standards and metadata throughout the R&D data lifecycle.
Study Automation Workbench
Nurocor Study Workbench provides the necessary tools for configuring the MDR standards and the output from the apps in the Clinical Lifecycle suite for study use.
Tables, Figures, and Listings Specifications
Nurocor Tables, Figures, and Listings Specification app enables a study statistician to configure the Tables, Figures, and Listings requirements for a study from the Tables, Figures, and Listings reference library stored in the Digital Asset Repository.
Study Data Tabulation Model Generator
Nurocor Study Data Tabulation Model Generator utilizes the conceptual model for transformations and mapping between lifecycle stage standards to automate the creation of Study Data Tabulation Model datasets. The mapping and transformation logic stored in Nurocor Digital Asset Repository is transformed into executable code (SAS, R, and others) and handed over to your statistical computing environment through system integration.
Analysis Data Model Generator
Nurocor Analysis Data Model Generator utilizes the conceptual model for transformations and mapping between lifecycle-stage standards to automate the creation of Analysis Data Model datasets. The mapping and transformation logic stored in Nurocor Digital Asset Repository is transformed into executable code (SAS, R, and others) and handed over to your statistical computing environment through system integration.
Tables, Figures, and Listings Generator
Nurocor Tables, Figures, and Listings Generator automates the creation of Study Data Tabulation Model datasets by utilizing the mapping and transformation logic stored in Nurocor Digital Asset Repository.
Clinical Study Report
A standards-driven, template-based digital Clinical Study Report incorporates digital content from the Nurocor Digital Asset Repository, the Nurocor Clinical Lifecycle suite of apps, and Nurocor Study Workbench.
Study Data Reviewers Guide
A standards-driven, template-based digital Study Data Reviewers Guide incorporates digital content from the Nurocor Digital Asset Repository, the Nurocor Clinical Lifecycle suite of apps, and the Study Workbench.
Nurocor Clinical Platform Dashboard
The Nurocor Clinical Platform Dashboard is the central location for accessing your information and data within the platform.
Study Designer
Nurocor Study Designer enables you to create and maintain your study design from the ground up.
Study and Protocol Elements
Study and Protocol Elements turn your study’s text documents into a connected and structured part of your Nurocor Clinical Platform solution.
Schedule of Activities
Nurocor Schedule of Activities guides study designers through an intuitive process of schedule specifications, study events, and planned activities.
Change Request
Nurocor Clinical Platform implements common workflow and change request services in support of consistent cross-platform change requests.
Protocol
A standards-driven, template-based digital protocol incorporates digital content from the Nurocor Digital Asset Repository and Nurocor Clinical Lifecycle suite of apps. In digital form, the protocol becomes an active component of the digital data flow and is the critical link between clinical trial planning and downstream clinical systems and processes.
Statistical Analysis Plan
A standards-driven, template-based digital Statistical Analysis Plan incorporates digital content from the Nurocor Digital Asset Repository, the Nurocor Clinical Lifecycle suite of apps, and the Tables, Figures, and Listings Specification app.
Data Review and Monitoring Plan
A standards-driven, template-based digital data review and monitoring plan incorporating digital content from the Nurocor Digital Asset Repository, Nurocor Clinical Lifecycle suite of apps, and the Study Workbench.
Data Transfer Specification
A standards-driven, template-based digital Data Transfer Specification incorporates digital content from the Nurocor Digital Asset Repository, Nurocor Clinical Lifecycle suite of apps, and the Study Workbench.
Risk Management Plan
A standards-driven, template-based digital Risk Management Plan incorporates digital content from the Nurocor Digital Asset Repository, the Clinical Lifecycle suite of apps, and the Study Workbench.
Authoring
Authoring app – A generic authoring microservice that can be driven from authoring templates; for example, Protocol, Statistical Analysis Plan, and CSR. Auth integrates with the structured model and shares content created by other Nurocor Clinical Platform apps.
Lean Protocol™
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.
Electronic Data Capture
Electronic Trial Master File
Clinical Trial Management System
Digitalization has been thrust to the fore since the advent of the COVID-19, and not just for the Biopharma industry. Development of the COVID-19 vaccines necessitated new methods of working, e.g., decentralized trials, and laid bare the brittleness of existing processes and systems to the point where the layman is familiar with many of the challenges the industry faces. Few will argue against digitalization as the right solution. The question is more, how you digitalize the document heavy and manual processes that exist today to provide the holistic and cohesive solution required.
The ever-increasing complexity of clinical trials requires a paradigm shift in clinical operations. The clinical development process of the future must address the full people / process/ product framework in a fully digitalized manner. The willingness of the industry to do this is clearly there but of the $1.3 trillion that was spent on Digital Transformation last year, it was estimated that $900 billion went to waste. This is mainly due to the lack of a holistic approach to implementation.
Nurocor is a leader in the digitalized clinical development space providing a clear strategic roadmap addressing all aspects to the people/process/product framework. Customers execute the digitalization project on a planned schedule and at their own pace, to realize a continuing and growing return on the investment in the solution.
(1. Behnam Tabrizi, Ed Lam, Kirk Girard, and Vernon Irvin – Harvard Business Review – Digital Transformation Is Not About Technology)
Nurocor Clinical Platform
Digitalized Clinical Development drives automation and standardization.
Nurocor Clinical Platform (NCP)
is a platform enabling automation and harmonization of business processes through application of robust and connected standards. It is not a single application, but a pool of applications that can be utilized across the clinical development lifecycle. It is fully digitalized – all the way from study to program to portfolio.
Clinical Development Plan
is a Design Center 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.
Protocol and Study Design
is the critical component of the digitalized clinical development process. In digitalized form, protocol content can directly connect to downstream standards ensuring the protocol never deviates from standards, and automates study EDC builds for rapid deployment. A number of dedicated and focused apps support the development of protocol content:
- Study Designer
- Objectives and Endpoints
- Study and Protocol Elements (SPE)
- Schedule of Activities (SOA)
- Authoring
Statistical Analysis Plan
The SAP application takes objectives, endpoints and/or estimands which are defined in the digital protocol as the starting point. You can utilize the SAP application to associate analytical method information using automated suggestions from reference libraries, and configure TFL templates required by the study.
Data Collection
The SOA application’s simple interface connects to standards both upstream (objectives and endpoints) and downstream (data collection/SDTM/ADaM) providing automation for rapid study builds.
Data Tabulation
The SDTM application utilizes mapping and transformation metadata defined in MDR reference libraries for EDC and non-EDC sources to automate the generation of SDTM datasets. Relationships between data collection and SDTM specifications defined in the reference libraries enables you to set up the initial SDTM transformation code at the same time as you define the data collection specification.
Data Analysis
Utilizing mapping and transformation metadata curated and managed in the MDR, the ADaM application automates the generation of standard ADaM datasets.
Submission
The NCP generates a number of study level submission deliverables such as Define-XML, aCRF, and SDRG.
Data Standards Management
The functional foundation of NCP is Nurocor MDR™. Nurocor MDR, in combination with the Vision NCP application, supports the definition, review, and approval and provisioning of industry-defined and customer-specific clinical lifecycle standards.
Nurocor Clinical Platform transforms clinical trial research from a paper-based process into a meaningful collaboration among teams. The platform leverages submission standards to ensure protocol content is reusable across the clinical development lifecycle. Digitalized protocol content drives downstream automations through parallelized workflows.
Nurocor Clinical Platform is an enterprise class, cloud-based, highly scalable technology platform for Nurocor’s suite of standards-driven digitalized clinical development applications. Each application is developed with its own technology stack and deployed as a microservice within Nurocor Clinical Platform, with the platform featuring a unified user interface experience across applications.
Need More Info?
For more information about Nurocor, and how Digitalized Clinical Development can help you, please browse our Resources or Contact Us.
Nurocor provides the industry-leading platform for digitalized clinical development to help companies bring drugs to market faster. Automating the Nurocor Lean Protocol™ with Nurocor Clinical Platform delivers a front-loaded, workflow-driven, digital process enabling the parallelization of business processes to significantly reduce the time required for clinical development.
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