CTMS

Ennov CTMS is a comprehensive Clinical Trial Management System software designed for clinical teams of all sizes. It centralizes operational trial data to simplify the planning, management, and reporting of clinical trials from start to finish. By replacing disconnected spreadsheets, emails, and siloed systems with a single authoritative source of record, Ennov CTMS gives sponsors, CROs, and research sites the visibility and control they need to manage studies more efficiently and make decisions based on accurate, up-to-date metrics.

The platform supports the full clinical trial lifecycle — from site selection and activation through patient recruitment, monitoring, financial tracking, and portfolio-level reporting. It is built on Ennov's Unified Compliance Platform, incorporating Ennov Workflow for business process management, Ennov Doc for document management, and Ennov Analytics for reporting and data visualization, and integrates directly with Ennov Clinical Data Management applications including Ennov EDC.

Core Capabilities

• Comprehensive organization and personnel directories covering investigators, sub-investigators, study coordinators, pharmacists, hospitals, competent authorities, CROs, and suppliers
• Patient recruitment and enrollment tracking
• Query and deviation tracking
• Adverse event tracking
• Drug supply management
• Financial and budget tracking
• Robust monitoring visit planning and scheduling capabilities

Key Features

• Centralized database serving as a single system of record for all operational trial data
• Integrated workflow engine for automated assignments, approvals, and reminders
• Comprehensive and configurable data model with a preconfigured core model for faster implementation
• Intuitive, user-centric interface
• 100% web-based architecture, highly scalable across studies and sites
• 21 CFR Part 11 compliant, supporting regulated life sciences environments
• Secure role-based access for internal teams and external partners
• Integration with Ennov CDMS, enabling study information from Ennov EDC to be imported directly to reduce duplicate data entry and accelerate study startup

Advanced Analytics and Risk-Based Trial Management

• Pre-configured CTMS dashboards that consolidate key trial information including status, progress, risks, and outliers across the portfolio
• Visibility into recruitment and enrollment, site and subject status, protocol deviations and CAPAs, health authority status, adverse events, and query trends
• Dashboards reflecting recommendations from industry initiatives such as TransCelerate
• Filterable views by study, country, and investigational site with export functionality to support ongoing reporting and team reviews
• Full complement of reports providing total visibility into the status of each study, country, site, and investigator

Compliance and Inspection Readiness

• Controlled workflows with traceability of updates and decisions to support audit-ready documentation
• Structured records and consistent documentation practices to support inspection readiness
• Role-based access control to maintain governance while enabling collaboration
• Configurable processes and roles to align with organizational SOPs and operating models
• ISO 9001 and ISO 27001 certified platform

Out-of-the-Box Workflows Supported

• Study setup and planning
• Site onboarding and status tracking
• Activity and milestone tracking
• Monitoring and visit scheduling
• Task routing and approvals
• Operational reporting through dashboards

Ennov CTMS is available as a cloud-based or on-premises deployment, with the flexibility to switch between options at any time. System configuration and management require no IT skills, enabling teams to remain fully autonomous. The platform is part of the broader Ennov Clinical Suite, which also includes eTMF, EDC with ePRO, and RTSM, and is trusted by over 500,000 users across more than 450 life sciences customers worldwide.