CTMS

Trial Interactive's Clinical Trial Management System (CTMS) is a next-generation, mobile-first platform designed to empower every stakeholder in clinical operations — from CRAs and study managers to IT teams and business leadership. By simplifying study planning, oversight, and reporting, TI CTMS removes friction from day-to-day clinical workflows, enabling faster risk-based decisions and reduced cycle times across global trials.

Built for pharmaceutical and biotech organizations, TI CTMS delivers 360° clinical trial management through real-time visibility, seamless eClinical interoperability, and robust compliance controls. The system is highly configurable to adapt to existing business processes and is backed by 24/7 global support, enabling rapid implementation and go-live.

Planning & Management Capabilities

• Activity plans with milestones for structured trial execution
• Visual reporting through intuitive dashboards covering enrollment, milestones, activities, documents, and plans
• Clinical portfolio, program, and product management across the enterprise
• Country and region management for global trial oversight
• Subject and subject visit management
• Flexible support for many trial designs
• Site activation and study start-up tracking

Insight & Audit Features

• Author-to-archive site portal with direct integration to eTMF
• Letters and report creation tools
• Clinical trial performance reporting with configurable reports and custom fields
• Sponsor, site, vendor, and lab management in a single system
• Real-time audit trail capturing tasks, data, and correspondence to mitigate compliance risks

Monitoring & Compliance Tools

• Full compliance with 21 CFR Part 11 and EU Annex 11 regulatory standards
• Mobile app for site management and monitoring activities, enabling CRAs to work anytime, anywhere
• Protocol deviation and issue tracking for proactive risk management
• Document workflows with eSignature approvals
• Built-in, best-in-class content management and eTMF integration
• Improved data quality through standardized business practices

Study Management Functionality

• Visual dashboards providing oversight of enrollment, milestones, activities, documents, and plans
• Study View offering a clear layout of countries, sites, organizations, contacts, activities, milestones, and documents
• Milestone tracking showing planned and actual milestones by date, priority, and risk
• Comprehensive study team management with simplified access rights and a single source of truth for metadata
• Activity plan templates that can be published and applied across multiple countries, sites, studies, and subjects

Site Management Functionality

• Site View providing a complete layout of regions, site users, organizations, contacts, activities, milestones, deviations, issues, and communications
• Site visit reports covering visit schedules, planned and completed activities, protocol information, ICF tracking, deviations, and safety reports
• Site selection and management with oversight of the site selection process and study start-up status
• CRA visit report management including communication logs, site roles, IP and supply shipment addresses, and CRA assignments
• eTMF and essential document tracking with seamless publishing to the TI eTMF
• KPI monitoring including deviation and safety trends, visit report cycle times, and screening failure trends

TI CTMS connects seamlessly to Trial Interactive's broader 21 CFR Part 11 compliant eClinical platform, which includes eTMF and TMF services, content management, study start-up, and learning management solutions. This integration provides a complete, centralized environment for both on-site and remote clinical trial management, supporting interoperability across the full clinical operations ecosystem.