Clinical Trial App Builder with Real-Time Simulation
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Solution Overview
Problem
Existing methods for creating mobile applications for clinical trials are inefficient, requiring extensive software development knowledge and taking weeks or months to develop, and are not scalable or flexible, failing to provide a suitable testing environment that replicates minimal functionality needed for clinical testing.
Innovation Solution
A system and method for building clinical trial applications that uses a software platform to pose iterative questions to users, allowing real-time construction and simulation of applications, incorporating clinical and consumer medical monitoring devices, and enabling data processing and modification based on user feedback, facilitating intuitive design and real-time data access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional software development methods are used to create mobile applications for clinical trials, then the applications can be fully functional and tested, but the development process requires extensive programming knowledge and takes weeks or months to complete
Solution Approach 1:
The system enables non-programmers to create clinical trial applications through an intuitive question-based interface. The platform automatically generates functional applications by processing user responses to structured questions, eliminating the need for users to possess software development skills while maintaining full application functionality.
Solution Approach 2:
The patent introduces an intermediary software platform that acts as a mediator between the user's research requirements and the final application product. This platform translates user responses to questions into functional application code and configuration, bridging the gap between non-technical users and complex software development needs.
2Reliability
If traditional software development methods are used, then comprehensive testing can be performed, but the development time extends to weeks or months
Solution Approach 1:
The system performs preliminary actions by pre-defining testing frameworks, validation rules, and quality assurance protocols within the question-based platform. Testing configurations are established in advance through the question responses, allowing comprehensive validation to occur automatically during the rapid application generation process rather than requiring separate extended testing phases.
Solution Approach 2:
The platform maintains continuous useful action by integrating application creation, configuration, and testing into a single uninterrupted workflow. As users respond to questions and define their clinical trial requirements, the system continuously generates and validates the application in real-time, eliminating idle time between development and testing phases.
3Adaptability or versatility
If traditional development approaches are used, then applications can be created, but they are not scalable or flexible with respect to changes in demand or focus
Solution Approach 1:
The system embodies dynamics by allowing real-time modification and adaptation of application parameters through the question-based interface. Users can easily adjust study protocols, add or remove endpoints, and modify data collection requirements by simply updating their responses to the platform's questions, enabling the application to dynamically adapt to changing research demands without requiring redevelopment.
Solution Approach 2:
The patent creates a universal platform that can generate diverse clinical trial applications across multiple study types and therapeutic areas through a single question-based interface. The system handles various application requirements uniformly, making it adaptable to different research focuses and scalable to meet varying demands while maintaining consistent development efficiency.
Data Source
AI summary
The present invention allows clinical trial organizers to operate a platform for creating trial specific custom mobile applications at a price point that would not be possible if the application were created by programmers on a trial-by-trial basis. The invention shortens build time by creating a hierarchy of questions that changes the next question posed to the user based upon their answer to a previous question thereby reducing the number of questions the user must answer while providing the application creation platform with the detailed information relevant to a specific clinical trial. The platform uses a simulation builder that provides a test version of the application to the user mobile device during the application creation process thereby allowing the user to see the layout of the application as they progress through the building process. While building the application, the user can create a simulated version of the application in real time deliver the same to the mobile device of the user. The system creates a handshaking process that allows the user to create annotations and/or edits in the simulated application that are communicated back to the building platform. Changes made in the simulated application will affect the landing page the user sees when returning to the building platform. The system will collect usability data from a clinical trial application on a plurality of trial subject and trial organizer mobile devices. The system can measure variables such as time on page, misentries, and missed selections of icons to determine common trouble spots for users. That data may be used to redesign the interface or process flow of the application to optimize usability.