Development of a Secure, Scalable Electronic Trial Master File (eTMF) System for Clinical Trial Document Management

The client faces difficulties in managing complex clinical trial documentation workflows, ensuring data integrity, regulatory compliance, and secure, global access to files, which hampers operational efficiency and data security across multiple trial phases.

A mid-sized life sciences company or clinical research organization specializing in managing and overseeing clinical trial documentation and processes.

• Develop a secure, scalable, and compliant electronic document management system tailored for clinical trials.
• Enable users to access, edit, and store trial documents centrally with high security and data protection measures.
• Implement structured workflows including automated QC, document naming, status tracking, and trend analysis features.
• Create customizable dashboards and planning tools to streamline logistics, safety reporting, data collection, and analysis.
• Facilitate seamless collaboration among sponsors, CROs, and stakeholders to improve operational efficiency and regulatory adherence.

• Secure, centralized storage for clinical trial documents accessible globally
• Structured processes with enforced quality control and compliance protocols
• Automatic document naming conventions and status monitoring dashboards
• Tools for planning, maintenance, and exposure of trends and bottlenecks in workflows
• Collaborative environment supporting multi-user access and version control
• Customizable dashboards for tracking trial progress and operational metrics

• Regulatory compliance validation tools
• Data analysis and visualization modules
• Existing clinical trial management systems (CTMS)
• Document QC and naming automation tools
• Security and authentication services

• System scalability to support large volumes of trial documents with a target of supporting multiple concurrent users worldwide
• High availability with 99.9% uptime and disaster recovery provisions
• Robust security measures including encryption, role-based access, and audit trails
• Performance optimized for quick response times in document retrieval and status updates
• Compliance with industry regulations such as GDPR, HIPAA, and 21 CFR Part 11

The implementation of this system is expected to significantly improve document management efficiency, enhance regulatory compliance, reduce trial document processing time, and enable comprehensive trend and bottleneck analysis, ultimately supporting faster trial progress and improved data integrity across clinical phases.