Rave eTMF (electronic Trial Master File) is a cloud-based solution designed to simplify and automate the management of clinical trial documentation. It offers streamlined document filing, auto-population of content, and integration with other Medidata Platform applications, ensuring a contemporaneous and inspection-ready Trial Master File.

Key Features

Comprehensive Search Advanced search algorithms for efficient document retrieval

• Content, title, and metadata-based search
• Standardized content management for regulated and non-regulated documents

TMF Reference Model Support Full compatibility with industry standards

• Drug Information Association (DIA) TMF reference model included
• Out-of-the-box DIA file plan configuration

Dashboards and Reporting Real-time oversight and document access

• Comprehensive dashboards for monitoring trial progress
• Reporting tools to maintain inspection-readiness

Intelligent Placeholders Automated document package creation

• Event-triggered placeholder generation
• On-demand package creation and triggering

Benefits

Streamlined Study Conduct Unified solution for efficient trial management

• Integration with Rave EDC and Rave CTMS
• Complete picture of clinical trial progress
• Improved inspection readiness

Faster Implementation Rapid deployment and setup

• Minimal IT involvement required
• Implementation timeline as short as 8 weeks

Simplified TMF Management Efficient document filing and organization

• Auto-population of content from integrated applications
• Quick generation of new study plans
• Customizable file plans

Enhanced Collaboration Real-time teamwork across stakeholders

• Shared access for sites, sponsors, and CROs
• Single platform for creating, storing, viewing, and editing TMF content