Development of a Cross-Platform Mobile Adverse Event Reporting System for Healthcare Organizations

Healthcare organizations and patients face difficulties in reporting adverse drug reactions and complaints promptly due to the lack of accessible, real-time mobile solutions. Existing systems are predominantly web-based, limiting the ability to capture critical safety data on the go, leading to delays and increased manual effort in data collection and analysis.

A mid-sized healthcare technology provider specializing in pharmaceutical data solutions aiming to enhance drug safety and patient engagement through mobile data capture.

• Automate and streamline adverse event and patient complaint reporting processes for healthcare professionals and patients.
• Enable real-time data capture and submission through a cross-platform mobile application functioning offline with data synchronization capabilities.
• Reduce manual effort and processing time for adverse event reports, aiming for at least a 95% reduction in manual report creation efforts and doubling of submitted reports.
• Improve timeliness of safety feedback, supporting faster decision-making in drug safety management.
• Ensure compliance with data security standards such as HIPAA and GDPR, safeguarding sensitive health information.
• Provide a white-label mobile solution allowing organizations to customize branding, interface, and functionality.

• User authentication and role management for healthcare professionals and patients.
• Easy navigation to create new reports or review existing ones.
• Dynamic, condition-based form fields using intelligent questioning logic.
• Capture of detailed information, including suspect products, adverse event descriptions, duration, and contact details.
• Offline mode support with automatic data synchronization when connectivity is restored.
• Secure data transmission with encryption and SSL pinning to ensure compliance with GDPR and HIPAA.
• Customizable interface with white-labeling options for branding and UI/UX adjustments.
• Notification system for timely feedback and report status updates.

• Safety database or secure data repository for report storage
• Authentication and identity management systems
• Notification and messaging services
• Data synchronization services for offline mode

• High security standards complying with HIPAA and GDPR
• Offline mode with data synchronization in background
• Scalable architecture capable of supporting increasing user base
• Performance optimized for quick form loading and response handling
• Reliable data encryption and secure communication channels

The implementation of the cross-platform mobile adverse event reporting application is expected to significantly enhance data collection efficiency, reduce manual reporting efforts by over 95%, double the number of reports submitted, and accelerate reporting times by a factor of two. These improvements will lead to more timely safety feedback, better patient outcomes, and strengthened compliance with regulatory standards, ultimately fostering more effective drug safety management.