Mobile Platform for Clinical Trial Data Management
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Solution Overview
Problem
Conventional tools for managing clinical trials are inefficient due to legacy technology, failing to leverage mobile devices and location-based information, leading to challenges in patient recruitment, enrollment, and site management, resulting in increased costs and complexity.
Innovation Solution
A mobile administrator platform that gathers and stores content associated with clinical protocol workflow steps, allowing for contextual communication and document management across multiple clinical research sites, utilizing location-based services to streamline site startup, monitoring, and reporting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional legacy tools are used for managing clinical trials, then existing systems can maintain current operations, but efficiency and scalability are limited leading to increased costs and complexity
Solution Approach 1:
The patent replaces conventional legacy mechanical and manual systems with a mobile-first digital platform that uses smartphones, tablets, and wearables to capture, transmit, and manage clinical trial data. This substitution of mechanical/manual processes with electronic mobile technologies directly improves efficiency while managing system complexity through familiar consumer devices.
Solution Approach 2:
The mobile platform serves multiple functions including patient recruitment, enrollment, monitoring, data collection, and site management through a single integrated system. This multi-functionality approach improves overall productivity by consolidating previously separate processes into one universal platform.
2Reliability
If mobile devices and location-based services are integrated into clinical trial management, then real-time monitoring and data capture improve, but system complexity and implementation challenges increase
Solution Approach 1:
The system enables participants to self-report data, self-monitor their own trial progress, and automatically transmit information through their personal mobile devices. This self-service approach improves data capture accuracy while reducing the complexity of manual data entry and verification processes.
Solution Approach 2:
The platform implements real-time feedback mechanisms where data captured from mobile devices is immediately transmitted to the central system, providing instant verification and enabling prompt corrective actions. This feedback loop enhances reliability by ensuring data accuracy while managing complexity through automated validation.
3Productivity
If remote demand-based management is implemented across multiple clinical locations, then coordination and monitoring improve, but communication and management complexity increase
Solution Approach 1:
The patent introduces a new dimension of remote management by enabling clinical trial coordination across multiple geographically dispersed locations through mobile technology. This spatial dimensionality change allows real-time monitoring and communication across sites without increasing physical coordination complexity.
Solution Approach 2:
The system performs preliminary actions by pre-configuring mobile devices with trial protocols, pre-establishing communication channels, and pre-loading necessary forms and procedures. This preliminary setup improves ongoing management efficiency while reducing the complexity of real-time coordination.
Data Source
AI summary
A system and a method for managing one or more clinical protocols across multiple locations, including identify a clinical research location; capture a plurality of types of content from the administrator mobile device; analyze the captured content to determine one or more associated clinical protocols for the clinical research location; automatically select a workflow algorithm for each determined clinical protocol, the workflow algorithm configured to obtain stage based information and workflow items from the data store; and enable a mobile control interface for each determined clinical protocol, wherein the mobile control interface comprises monitoring of the stage based information and management of the workflow items associated with the clinical research location.