OpenClinica
The eClinical platform for patient-centric research.
Overview
OpenClinica is a leading open source electronic data capture (EDC) platform for clinical research. While its primary function is data collection and management for clinical trials, it includes features for data extraction and integration with statistical software for analysis. It helps make clinical trial data more organized, secure, and ready for biostatistical review.
✨ Key Features
- 21 CFR Part 11 compliant electronic data capture (EDC)
- Electronic patient-reported outcomes (ePRO)
- Randomization and trial supply management (RTSM)
- Data extraction in multiple formats (SPSS, SAS, CDISC)
- Real-time data validation and query management
🎯 Key Differentiators
- Open source foundation provides flexibility
- Strong focus on patient-centric features like ePRO
- Compliance with key clinical trial regulations (21 CFR Part 11)
Unique Value: Provides a compliant and feature-rich platform for capturing clinical trial data, ensuring data quality and integrity from the start, which is the foundation of any valid biostatistical analysis.
🎯 Use Cases (4)
✅ Best For
- Capturing and managing patient data for a multi-site oncology trial.
- Deploying ePRO forms for patients to complete at home.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Users who need to perform the statistical analysis itself within the tool
- Basic laboratory research not involving clinical trials
🏆 Alternatives
While not a statistical analysis tool itself, OpenClinica is a critical upstream component. Compared to REDCap, it offers a commercially supported, validated SaaS option with a stronger focus on regulatory compliance for industry trials.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Enterprise tier)
🔒 Compliance & Security
💰 Pricing
✓ 14-day free trial
Free tier: Open source community edition is available for self-hosting.
🔄 Similar Tools in Biostatistics Software
SAS/STAT
Advanced statistical analysis software for data-driven insights....
IBM SPSS Statistics
User-friendly software for statistical analysis, data management, and visualization....
Stata
Integrated statistical software for data science and research....
GraphPad Prism
Scientific graphing, curve fitting, and statistical analysis software....
JMP
Visual and interactive statistical analysis software....
Minitab Statistical Software
Statistical software for quality improvement and statistics education....