OpenClinica
Capture, manage, and analyze clinical research data.
Overview
OpenClinica is a leading open-source clinical trial software for electronic data capture and clinical data management. It offers both a free, open-source Community version and a supported Enterprise SaaS version. The platform is designed to be flexible and compliant, serving a wide range of users from academic researchers to global biopharmaceutical companies.
✨ Key Features
- Electronic Data Capture (EDC)
- Electronic Patient-Reported Outcomes (ePRO)
- Randomization & Supply Management
- Reporting & Data Extraction
- Form & Study Design Tools
- Compliance with 21 CFR Part 11
🎯 Key Differentiators
- Open-source foundation provides flexibility and a large community
- Integrated patient recruitment and EDC services
- Strong capabilities for EHR-to-EDC data integration
Unique Value: Combines the flexibility and transparency of open-source technology with enterprise-grade features and support, now including integrated patient recruitment to streamline the entire trial process.
🎯 Use Cases (3)
✅ Best For
- Investigator-led clinical trials and public health studies.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Organizations seeking a fully integrated, top-down operational CTMS without any IT involvement.
🏆 Alternatives
Unlike purely proprietary systems, OpenClinica's open-source roots offer greater control and customization options. Compared to other open-source tools like REDCap, it provides more robust commercial support and features.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Dedicated Support (Enterprise tier)
🔒 Compliance & Security
💰 Pricing
Free tier: Community version is self-hosted and has limited features/support.
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