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Development of an Innovative Clinical Trial Management Mobile Application for Enhanced Data Management
  1. case
  2. Development of an Innovative Clinical Trial Management Mobile Application for Enhanced Data Management

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Development of an Innovative Clinical Trial Management Mobile Application for Enhanced Data Management

10clouds.com
Medical
Information technology

Challenges in Clinical Trial Data Management

Existing clinical trial management platforms are outdated, inefficient, and fail to meet the evolving needs of medical researchers. Current systems lack user-friendly interfaces for data capture, participant enrollment, and informed consent management, leading to time-consuming processes and compromised data quality.

About the Client

Healthcare technology company specializing in cloud-based clinical data management solutions

Objectives for the Clinical Trial Management Solution

  • Create an innovative mobile application to modernize clinical trial workflows
  • Improve efficiency in trial design, deployment, and data management
  • Enhance data quality through intuitive electronic data capture (eCRF) systems
  • Streamline participant enrollment and informed consent processes
  • Establish a scalable platform for future clinical research advancements

Core System Functionalities and Key Features

  • Customizable trial design and deployment tools
  • Electronic case report form (eCRF) builder
  • Secure participant enrollment system
  • Digital informed consent capture and management
  • Real-time data visualization and export capabilities
  • Cloud-based storage with version control
  • Role-based access management for clinical teams

Technology Stack Preferences

React Native for cross-platform mobile development
Node.js with Express for backend API
AWS cloud infrastructure
MongoDB for NoSQL database
Figma for UX/UI design

Required System Integrations

  • Electronic Health Record (EHR) systems
  • Blockchain for audit trail security
  • HIPAA-compliant data storage solutions
  • Third-party authentication providers

Non-Functional Requirements

  • HIPAA and GDPR compliance
  • High-availability cloud architecture
  • End-to-end data encryption
  • Scalable infrastructure for global trials
  • Sub-second response times for core operations

Expected Impact on Clinical Research Efficiency

The new platform is projected to reduce clinical trial setup time by 40%, improve data accuracy through automated validation, and enable faster regulatory submissions through standardized reporting. By modernizing clinical data workflows, the solution will accelerate medical research timelines while maintaining strict compliance with healthcare regulations.

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