Digital Labels And Controlled Packaging For Clinical Trial Supplies
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Solution Overview
Problem
Clinical trial workflows face inefficiencies and inaccuracies due to labor-intensive physical labeling, errors in labeling processes, and challenges in maintaining temperature-controlled storage, leading to potential compromises in trial integrity and waste of unused products across disparate studies with varying regulatory compliance requirements.
Innovation Solution
A system utilizing digital labels and controlled packaging with active and passive cooling technologies, connected to a computer network for real-time monitoring, enabling flexible labeling, reusability, and efficient allocation of medicinal products across studies while adhering to regulatory requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If physical labels are used for medicinal products, then labeling provides necessary identification and compliance information, but the labeling process becomes labor-intensive and error-prone
Solution Approach 1:
The patent replaces physical labels with digital labels that can be dynamically updated and managed through a centralized system. Digital labels provide the same identification and compliance information as physical labels but eliminate manual labeling operations, reducing both labor intensity and error rates while maintaining full traceability and regulatory compliance.
Solution Approach 2:
The patent substitutes the mechanical process of physically applying labels with an electronic system that displays digital labels on screens or electronic devices. This replacement eliminates the manual operations involved in physical label application while maintaining the essential function of product identification and compliance information display.
2Reliability
If physical labels are updated or corrected, then accurate information is maintained, but the entire batch must be relabeled causing time loss and increased cost
Solution Approach 1:
The patent implements dynamic digital labels that can be updated in real-time through software without requiring physical replacement. When information corrections are needed, the system simply updates the digital display, eliminating the time-consuming process of removing and replacing physical labels while ensuring information accuracy is maintained through centralized control.
Solution Approach 2:
The patent uses digital copies of label information that can be modified and redistributed instantly across all products in a batch. This eliminates the need to physically relabel entire batches when corrections are needed, as the digital information can be updated and re-displayed immediately across all electronic devices showing the labels.
3Reliability
If separate supply chain pipelines are used for each study, then regulatory compliance is maintained, but product waste increases due to inability to re-allocate
Solution Approach 1:
The patent implements a universal digital labeling system that can dynamically adapt to different study requirements and regulatory frameworks. The same physical product can be assigned different digital labels for different studies, allowing flexible re-allocation of products across multiple studies while maintaining compliance with each study's specific regulatory requirements through customized digital label content.
Solution Approach 2:
The patent uses dynamic digital labels that can be changed in real-time to reflect different study assignments. When products need to be re-allocated from one study to another, the system simply updates the digital label information rather than requiring physical relabeling or disposal, enabling flexible resource optimization while maintaining regulatory compliance through study-specific label configurations.
4Reliability
If temperature monitoring is implemented for cold chain management, then product quality is maintained, but system complexity and monitoring costs increase
Solution Approach 1:
The patent combines temperature monitoring functionality with the digital labeling system into an integrated platform. Temperature sensors and monitoring capabilities are merged with the existing digital label infrastructure, allowing quality monitoring to be performed through the same system that manages product identification and compliance information, thereby reducing overall system complexity and leveraging existing technological investments.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enhances labeling efficiency, reduces waste, ensures temperature-controlled storage, and optimizes product allocation, improving the accuracy and cost-effectiveness of clinical trials by minimizing errors and enabling real-time monitoring and compliance.
Implementation Method 1
controlled packaging with active and passive cooling technologies
Implementation Method 2
controlled packaging with active and passive cooling technologies
Implementation Method 3
sensors coupled to the controlled packaging for data reflecting one or more environmental conditions of an internal environment of the controlled packaging
Implementation Method 4
environmental conditions including temperature, light, humidity, and vibration
Implementation Method 5
environmental conditions including temperature, light, humidity, and vibration
Implementation Method 6
environmental conditions including temperature, light, humidity, and vibration
Data Source
AI summary
A medicinal supply management system manages distribution of medicinal supply. The system may implement a pooling algorithm for pooling studies together, across different countries, with different protocol labeling parameters and/or blinding parameters. The system may allocate unique identifiers for the pooled studies. The system may implement digital display labels on the medicinal product for up-to-date presentation of relevant information to healthcare providers administering the medicinal product. The system may further implement controlled packaging for maintaining proper storage of the medicinal product, e.g., during transport to the treatment site. The controlled packaging may further include sensors for monitoring the internal environment of the controlled packaging, to maintain proper storage of the medicinal product.