Clinical Data Exchange Controller for Automated Trial Updates

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Solution Overview

Problem

The existing clinical data management processes in clinical trials are inefficient due to the reliance on paper documents for communication among sponsors, CROs, and clinical sites, which hinders the timely and regulated exchange of clinical trial definitions, patient data, and other critical information.

Innovation Solution

A clinical data exchange system comprising a clinical data exchange controller, first, and second repositories, where configuration information is used to establish connections, define scopes of capacity, and set rules for data transfer, enabling automatic detection and copying of predetermined changes between repositories.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If paper documents are used for communication among sponsors, CROs, and clinical sites, then the exchange process is simple to implement, but the efficiency and timeliness of data exchange deteriorates

Engineering Contradiction:

Improveease of implementationVSAvoiddata exchange efficiency

Core Design Contradiction:

Ease of manufactureVSProductivity

Solution Approach 1:

The patent replaces the mechanical paper document exchange system with an automated electronic data exchange system. The clinical data exchange server automatically transfers data between sponsor system, CRO system, and clinical site system through electronic interfaces, eliminating manual paper handling while maintaining system simplicity through standardized protocols and automated processes.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Device complexity

If manual processes are used for data exchange, then the system complexity is low, but the timeliness and real-time updates of clinical data deteriorates

Engineering Contradiction:

Improvesystem complexityVSAvoiddata exchange timeliness

Core Design Contradiction:

Device complexityVSLoss of time

Solution Approach 1:

The clinical data exchange server implements self-service functionality by automatically detecting changes in source systems, determining the type of changes, and initiating data transfers without manual intervention. The system autonomously manages the entire data exchange process from detection to completion, reducing time loss while maintaining manageable complexity through automated rule-based operations.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system incorporates feedback mechanisms where the clinical data exchange server continuously monitors source systems for changes, receives feedback about data status and transfer outcomes, and adjusts its operations accordingly. This feedback loop ensures real-time data synchronization while maintaining system simplicity through automated response protocols.

Inventive Principle:

Principle #23Feedback

3Productivity

If automated data exchange is implemented, then the efficiency and real-time updates are improved, but the system complexity and configuration requirements increase

Engineering Contradiction:

Improvedata exchange efficiencyVSAvoidsystem configuration complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by pre-configuring the clinical data exchange server with source system definitions, data element mappings, and transfer rules before data exchange begins. The system is pre-programmed with the logic to detect change types and route data appropriately, reducing operational complexity while maintaining high efficiency during actual data exchange operations.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The clinical data exchange server is designed as a universal platform that can handle multiple types of source systems, data formats, and exchange scenarios through a single system architecture. It performs multiple functions including change detection, data validation, format conversion, and selective transfer, reducing the need for separate specialized systems while maintaining high efficiency.

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Ease of manufacture

If manual document transfer is used, then the configuration and setup are simple, but the labor intensity and manual requests required increase

Engineering Contradiction:

Improvesetup simplicityVSAvoidoperational ease

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The patent introduces a clinical data exchange server as an intermediary between source systems and target systems. This intermediary automatically manages the complex configuration and setup processes while providing simple operational interfaces to users. The server handles all manual requests and transfer operations autonomously, making the system easy to operate despite the automated complexity behind the scenes.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS11232871B1System and method for exchanging clinical data

Publication Date: 2022.01.25 VEEVA SYSTEMS INC

AI summary

Systems and methods for exchanging clinical data among parties involved in a clinical trial. The system comprises a clinical data exchange controller, a first repository and a second repository. Repository configuration information comprises: a connection to a target repository, scope of capacities, and a rule set. Repository configuration information for the first repository is received at the first repository, and repository configuration information for the second repository is received at the second repository. When there is a change defined in the rule set happened in the first repository, a request for data transfer is sent to the clinical data exchange controller, and the clinical data exchange controller then transfers the data to the target repository based on the rule set.