Development of a Centralized Patient Recruitment and Data Management Platform for Clinical Trials

The client faces difficulties in centralizing patient data, ensuring secure access across multiple clinics, and efficiently identifying suitable candidates for clinical trials. Current processes are fragmented, time-consuming, and lack real-time synchronization, impacting study timelines and operational efficiency.

A large pharmaceutical or clinical research organization managing multiple clinical trials across different regions, requiring efficient patient data handling and recruitment processes.

• Create a secure, centralized web-based platform for managing patient data across multiple clinics.
• Implement real-time data synchronization to ensure up-to-date patient information.
• Enhance usability through intuitive user interfaces tailored for clinic staff.
• Enable fast, reliable querying and analysis tools for identifying eligible patients for clinical trials.
• Ensure compliance with data security standards, including secure access and audit logging.
• Facilitate data import from legacy and new databases to support seamless transitions.

• Web application accessible via browsers built on a three-tier architecture (presentation, business logic, data layers).
• Secure user authentication with one-time password (OTP) and HTTPS protocol for data security.
• Clinic-specific data isolation ensuring privacy and data segregation.
• Comprehensive activity tracking and audit logs for all user operations.
• Version control and historical data storage to allow rollback and audit trails.
• High-performance, real-time data synchronization using SQL Server or equivalent database technology.
• Analysis interface providing fast lookup, filtering, and patient eligibility detection tools.
• Data import functionality supporting integration with legacy and current patient databases.

• Legacy and current patient database systems for data import and synchronization
• Secure authentication providers for OTP support

• System must support multi-tenant data segregation for multiple clinics
• Ensure high performance with real-time data synchronization to handle concurrent access
• Data security complying with healthcare privacy standards (e.g., GDPR, HIPAA)
• System reliability and availability to support 24/7 clinic operations
• Audit trail and version control for full traceability of all data and activities

The implementation of the centralized patient recruitment and data management platform is expected to accelerate clinical study timelines, improve data accuracy and security, and enhance operational efficiency across multiple clinics. Reliable real-time data synchronization and user-friendly interfaces will enable quicker identification of suitable candidates, ultimately reducing time-to-market for new therapies and increasing research productivity.