OpenClinica

Capture, manage, and analyze clinical research data.

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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)

Academic and government-funded research. Clinical trials requiring a flexible and cost-effective EDC. Organizations that want control over their software environment (via open-source).

✅ 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

REDCap Castor Medidata

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

Web API

🔌 Integrations

API for custom integrations

🛟 Support Options

  • ✓ Email Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ GCP

💰 Pricing

Contact for pricing
Free Tier Available

Free tier: Community version is self-hosted and has limited features/support.

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