DataLabs EDC

Ennov DataLabs EDC is a comprehensive, 100% web-based electronic data capture system designed to revolutionize clinical data management. Built for biopharmaceutical sponsors, contract research organizations (CROs), and medical device manufacturers, it delivers a flexible, reliable, and efficient platform that supports the entire clinical trial lifecycle — from study design through to data reporting.

Clinical trial management presents significant challenges, including meeting stringent regulatory requirements, maintaining data quality, ensuring patient safety, and optimizing resource allocation. Ennov DataLabs EDC addresses these complexities head-on with a robust suite of advanced features that reduce inefficiencies, lower costs, and minimize risks throughout the trial process.

Core Capabilities

• Targeted Source Data Verification (SDV): Focuses monitoring efforts where they are most needed, reducing on-site monitoring activities and associated costs while enabling data-driven decision-making.
• Real-time safety reporting: Enhances patient safety by providing up-to-the-moment visibility into safety data throughout the trial.
• Seamless system integration: Robust API web services enable comprehensive integration with various external systems, eliminating data discrepancies and ensuring end-to-end data management.
• Intuitive study build tools: A simple, user-friendly interface with drag-and-drop functionality facilitates rapid and intuitive study design.
• Comprehensive data management and reporting: Advanced analytics and reporting capabilities support informed decision-making across the study lifecycle.

Key Features

• Centralized repository for study design objects
• Built-in edit checks for data validation
• Drag-and-drop interface for rapid study builds
• Dynamic generation of patient-specific Case Report Forms (CRFs)
• Visual comparison of study design changes
• 21 CFR Part 11 compliant, fully web-based architecture

Why Choose Ennov DataLabs EDC

• Trusted by over 500,000 users across 450+ life sciences customers, backed by more than 25 years of industry experience.
• Modern, highly scalable, user-centric architecture that is 100% web-based.
• 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.
• System configuration and management require no IT skills, enabling full operational autonomy.
• Single-tenancy architecture minimizes business interruptions, with the option to host data locally for maximum flexibility.
• ISO 9001 and ISO 27001 certified, ensuring high standards of quality and information security.

Ennov DataLabs EDC is part of the broader Ennov Clinical Suite, which also includes eTMF (with eTMF Archive), CTMS, ePRO, and RTSM applications — all available for cloud or on-premises deployment. This integrated ecosystem enables organizations to efficiently and securely capture and manage clinical trial information across all operational areas.