Digital Data Flow:
Modernizing Clinical Trials, Updates on Progress and Cross Industry Collaboration (Part 2)
TransCelerate’s Digital Data Flow (DDF) initiative aims to transform clinical studies by enabling end-to-end digital exchange of study definition information. Join us for the second part of a two-part TransCelerate DDF public webinar to learn more about our progress on the initiative and engage with industry peers in a panel discussion for additional insights on digital data flow.
The Industry-Leading Platform for Digitalized Clinical Development
Note: Conservative projections based on publicly available costs and metrics. The projections do not include time to market benefits (for a blockbuster medication that would be $3M per day)!
Digitalization – Nurocor will take you there.
Nurocor Clinical Platform (NCP) provides a broad range of functional capabilities supporting key data standards, clinical lifecycle activities and processes. NCP is built to be future-proof based on state-of-the-art microservice architecture resulting in a composable platform enabling you to 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.
Roll over each icon to learn more about each application or feature.
The Nurocor Metadata Repository manages your standards and metadata throughout the R&D data lifecycle.
Study Automation Workbench
The 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.
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.
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.
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.
The Tables, Figures, and Listings (TFL) Generator automates the creation of SDTM datasets by utilizing the mapping and transformation logic stored in the MDR.
Clinical Study Report
A standards-driven, template-based digital Clinical Study Report incorporates digital content from the Nurocor Metadata Repository, the Clinical Lifecycle suite of apps, and the Study Workbench.
Study Data Reviewers Guide
A standards-driven, template-based digital SDRG incorporates digital content from the Nurocor Metadata Repository, the Clinical Lifecycle suite of apps, and the Study Workbench.
The NCP Dashboard is the central location for accessing your information and data within the platform.
The Study Designer enables you to create and maintain your study design from the ground up.
Study and Protocol Elements
Study and Protocol Elements turns your study’s text documents into a connected and structured part of your NCP solution.
Schedule of Activities
The Schedule of Activities guides study designers through an intuitive process of schedule specifications, study events, and planned activities.
The Nurocor Clinical Platform implements common workflow and change request services in support of consistent cross-platform change requests.
A standards-driven, template-based digital protocol incorporates digital content from the Nurocor Metadata Repository and the 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 SAP incorporates digital content from the Nurocor Metadata Repository, the 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 Metadata Repository, the 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 Metadata Repository, the 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 Metadata Repository, the Clinical Lifecycle suite of apps, and the Study Workbench.
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.
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)
The Nurocor Clinical Platform
Digitalized Clinical Development presents opportunities for 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)
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.
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.
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.
Utilizing mapping and transformation metadata curated and managed in the MDR, the ADaM application automates the generation of standard ADaM datasets.
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.
The Nurocor product offering significantly transforms clinical research from a paper-based world to a digital protocol driven collaboration platform. Protocols in digital form become digital assets where protocol development is informed by data standards right from the start, protocol information becomes actionable, and downstream automation is driven by integrated protocol and standards content.
Nurocor Clinical Platform (NCP) 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 NCP, 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 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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