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Development of a Cross-Platform Mobile Application for Automated Adverse Event Reporting and Patient Engagement
  1. case
  2. Development of a Cross-Platform Mobile Application for Automated Adverse Event Reporting and Patient Engagement

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Development of a Cross-Platform Mobile Application for Automated Adverse Event Reporting and Patient Engagement

itransition.com
Medical
Information Technology

Challenges in Manual Adverse Event Reporting

The absence of mobile solutions for on-the-go adverse event reporting led to manual data entry inefficiencies, delayed submissions, and limited patient engagement. Healthcare professionals and patients lacked a streamlined tool to report side effects and complaints in real time, hindering drug safety improvements.

About the Client

A SaaS provider delivering drug safety and adverse event reporting solutions to top global pharmaceutical organizations, focusing on patient protection and product data quality.

Goals for Mobile Adverse Event Reporting System

  • Automate adverse event data capture through a mobile platform
  • Enable real-time reporting for healthcare professionals and patients
  • Improve patient engagement through direct reporting capabilities
  • Ensure compliance with HIPAA and GDPR standards
  • Integrate offline reporting with background data synchronization

Core Functionalities and Features

  • Multi-role access (healthcare professionals, patients, pharma organizations)
  • Offline data entry with automatic synchronization
  • Dynamic form generation with conditional logic
  • Intelligent questioning based on user responses
  • White-labeling for brand customization
  • Secure submission to centralized safety database

Technology Stack Requirements

Xamarin.Forms
Portable Class Library (PCL)
Dynamic Form Rules Engine

System Integration Needs

  • Existing SaaS platform integration
  • Centralized safety database connectivity
  • HIPAA/GDPR compliance frameworks

Non-Functional Requirements

  • Data encryption (SSL Pinning, additional encryption layer)
  • Device security checks (rooting/jailbreaking detection)
  • Scalable cloud infrastructure for SaaS delivery
  • High-availability architecture
  • Cross-platform performance optimization

Expected Business Outcomes

Implementation of the mobile solution is projected to reduce manual reporting efforts by 95%, double the volume of submitted reports, and accelerate report creation by 50%. The application will enhance drug safety monitoring through timely data collection while maintaining regulatory compliance and enabling seamless user experiences across devices.

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