Nurocor listed as a Representative Vendor in the Gartner® Innovation Insight: Digital Protocol for Clinical Trials report
We are proud to announce that Nurocor has been identified a Representative Vendor in the Gartner Innovation Insight: Digital Protocol for Clinical Trials report. We believe this is a powerful recognition of our work in building the leading digitalized clinical development solution.
What is Digitalization?
Each Phase 3 Study:
Want to know more about DIGITALIZATION?
Turn Digital Transformation into Accelerated Clinical Development with the Nurocor Clinical Platform.
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)
- 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.
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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