IMPACT CTMS

Ennov IMPACT CTMS is a comprehensive Clinical Trial Management System designed to streamline and simplify the management of investigational sites and clinical trials of all types — from simple to complex. Built for any organization managing clinical trials, it delivers unparalleled visibility, enhanced trial quality, regulatory compliance, and improved productivity, equipping study teams with the tools they need to achieve better trial outcomes.

The clinical trial landscape presents growing challenges including rising regulatory demands, extensive data management requirements, and the need for timely, accurate trial execution. Without a robust CTMS, organizations risk increased costs, delays, and compromised data quality. Ennov IMPACT CTMS addresses these challenges head-on by centralizing operational data, automating workflows, and providing end-to-end compliance support.

Core Capabilities

• Comprehensive Site Monitoring: Includes a dedicated mobile monitoring app, enabling monitors to conduct and record site visits from anywhere.
• Issue and Protocol Deviation Tracking: Systematically captures and manages issues and deviations to maintain trial integrity.
• Investigator Payment Management: Robust tools to manage and track payments to investigators accurately and efficiently.
• Organization and Personnel Directories: Comprehensive directories to manage all organizations and personnel involved in trials.
• Subject Recruitment Tracking: Monitors planned versus actual recruitment and enrollment, enabling timely corrective action to avoid costly delays.
• Highly Configurable: Customizable checklists and key site information allow monitors to focus on the most critical tasks for each trial.

Key Features

• Centralized Global Database: Consolidates operational data from all historical trials into a single source of truth, facilitating cross-study analysis and trend identification.
• Out-of-the-Box Implementation: Rapid deployment with minimal setup time, backed by an experienced implementation and development team.
• Integrated Workflow: End-to-end workflows with electronic signatures ensure compliance and accountability throughout the trial lifecycle.
• Intuitive User Interface: User-centric design that is easy to navigate and requires no IT skills for system configuration and management.
• 100% Web-Based: Fully accessible via web browser with modern, scalable architecture.
• Self-Service Integration: Supports standard integrations with EDC, IRT, and eTMF systems, as well as custom integrations with financial ledgers, pharmacovigilance systems, and project management tools.
• 21 CFR Part 11 Compliance: Built to support regulatory compliance requirements for electronic records and signatures.

Automated Task Management and Alerting

• Automated task management keeps study teams on track with timely alerts and notifications.
• Customizable workflows ensure that critical activities are completed on schedule and nothing falls through the cracks.
• Centralized data enables identification of emerging trends and optimization of site selection based on historical trial performance.

Why Choose Ennov

• Over 25 years of experience providing software solutions for life sciences, with more than 450 life science customers and over 500,000 users trusting the Ennov platform.
• 98.5% of projects delivered on time and within budget, reflecting a strong commitment to customer success.
• Available as both cloud-based and on-premises deployments, with the flexibility to switch between options at any time.
• Single-tenancy architecture minimizes business interruptions, and data can be hosted locally for total flexibility.
• ISO 9001 and ISO 27001 certified, ensuring high standards of quality management and information security.

Ennov IMPACT CTMS is part of the broader Ennov Clinical Suite, which also includes eTMF (with eTMF Archive), EDC with ePRO, and RTSM — all available for cloud or on-premises deployment. The suite enables organizations to efficiently and securely capture and manage all clinical trial information within a unified, integrated platform.