Ennov EDC logo

Ennov EDC

by Ennov · Since 1999
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ActiveAvailable globallyCloudOn-premise
Quick facts
VendorEnnov
Year launched1999
StatusActive
Location149, Avenue de France, Paris, Île-de-France 75013, FR
Countries servedGlobal
Languages17
Integrations
Free tier
Free trial
Contact salesYES

About Ennov EDC

Ennov EDC is a clinical data management software from Ennov that simplifies data management in clinical research. It includes a Unified Compliance Platform, Regulatory Suite, and tools for document regulatory submission so researchers can efficiently capture and manage clinical trial information. The platform is accessible from any device, ensuring that users can interact with data anywhere. Ennov EDC also provides capabilities for RTSM, ePRO, CTMS, and Electronic Trial Master File, simplifying the entire clinical trial process. Key capabilities: Unified Compliance Platform Regulatory Suite Document for Regulatory Submission Publishing Ennov Dossier InSight Publishing Best for: clinical researchers and organizations that need to manage regulatory documents and clinical trial data effectively.

Ennov EDC is a robust and feature-rich electronic data capture solution designed for clinical trials of all sizes, offering a comprehensive suite that addresses the complex needs of life sciences organizations. Part of the broader Ennov Clinical Suite, it integrates seamlessly with other modules like CTMS, eTMF, and ePRO, providing a unified platform for managing clinical data, trial workflows, and regulatory compliance. One of its strongest selling points is its no-code study and form builder, allowing clinical teams to design studies without deep programming knowledge, significantly accelerating study startup times. The interface is intuitive and supports real-time validations and edit checks, which enhances data quality and integrity throughout the trial lifecycle. Ennov EDC is fully compliant with global regulations, including 21 CFR Part 11, GDPR, and CDISC standards, and also supports MedDRA and WHO Drug coding, making it highly suitable for regulated environments. Additionally, it supports multilingual deployments and both cloud-based and on-premises hosting, offering flexibility for global trial operations.

Pros & Cons

What users like
  • +Allows fast study setup with intuitive, no-code tools.
  • +Ensures strong regulatory compliance across regions and study types.
  • +Provides seamless integration between CRF, ePRO, randomization, and data reporting modules.
  • +Supports offline data entry on mobile devices, improving flexibility for remote trials.
  • +Offers a modern, user-friendly interface for both technical and non-technical users.
What users flag
  • Feature change requests or enhancements may be slow to implement.
  • May lack flexibility in very complex or atypical trial workflows.
  • Custom configurations may be challenging in highly specialized protocols.
  • Multilingual and localization support could be more robust in less common languages.

Features

Key features

No-Code Study Design
Enables study teams to design CRFs and configure workflows without programming knowledge.
Built-In Data Validations
Includes automated logic checks and edit rules to ensure clean, high-quality data entry.
ePRO Integration
Seamless integration with Ennov ePRO for collecting patient-reported outcomes.
Medical Coding Automation
Automatically codes terms using standard dictionaries like MedDRA and WHO Drug.
Data Import and Export
Supports structured imports and clean exports with traceable data lineage and full audit trail.

Additional features

Multisite, Multiphase Study Support
Suitable for Phase I–IV, epidemiological, and post-marketing studies across multiple global sites.
Device and Mobile Accessibility
Compatible with desktops, tablets, and mobile devices; optimized for iPad with offline data capture.
Advanced Field Logic
Supports dynamic activation of form fields, conditional logic, calculated fields, and value lists.
Regulatory Standards Compliance
Fully compliant with 21 CFR Part 11, GDPR, and CDISC/CDASH/SDTM standards.
Audit Trail and Traceability
Complete history of user activity, field modifications, and form versions for regulatory audits.
Randomization and Supply Management (RTSM)
Supports stratified randomization, treatment masking, and investigational product tracking.
Offline Data Capture
Data can be captured without an internet connection via iPad and synced later.
Real-Time Dashboards and Reporting
Offers visual dashboards to track enrollment, site progress, data quality, and protocol deviations.
Multilingual Interface
Provides support for multiple languages to accommodate global study teams and sites.

Pricing

Free trial
Free version
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Countries & Languages

Global
Countries served
17
Interface languages
17
Billing currencies

Interface languages

EnglishFrenchGermanSpanishItalianPortugueseDutchSwedishNorwegianDanishFinnishRussianJapaneseChinese (Simplified)Chinese (Traditional)KoreanArabic

Billing currencies

🇺🇸USD🇪🇺EUR🇬🇧GBP🇯🇵JPY🇦🇺AUD🇨🇦CAD🇨🇭CHF🇨🇳CNY🇭🇰HKD🇮🇳INR🇰🇷KRW🇲🇽MXN🇳🇿NZD🇷🇺RUB🇸🇪SEK🇸🇬SGD🇿🇦ZAR

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