OpenClinica
Claim ProfileDriving the future of digital clinical trials
SoftwareWorld Editorial Review
Why SoftwareWorld Chooses OpenClinica
"Clinical research teams often rely on OpenClinica to manage trial data in a more organized and trackable way. It helps with electronic data capture, making it easier to collect, monitor, and review information across study sites. Teams working on regulated trials appreciate having a structured system rather than managing data manually. That said, smaller organizations or those running simple studies may find the platform more involved than what they actually need."
Decision Snapshot
OpenClinica Evaluation Snapshot
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Trust & Transparency
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Structured Product Information
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Clear Sponsored Disclosure
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Editorial Independence
Sponsored participation does not influence SoftwareWorld's editorial assessment.
Data Transparency
Pricing and availability can change, so current details should be confirmed with the vendor.
Product Overview
OpenClinica Overview
Product description, media, company details, support, training, deployment, customer size, languages, and industries.
Support
Training
Licensing & Deployment
Typical Customers
Why Choose OpenClinica
Problem it Solves
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Streamlines Clinical Trial Data Management And Compliance For Researchers
Target Users
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Clinical Researchers
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Data Managers
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Study Coordinators
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Principal Investigators
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Regulatory Professionals
Core Use Case
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Collect Clinical Trial Data
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Manage Study Participants
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Monitor Study Progress
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Ensure Data Compliance
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Generate Study Reports
USP
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Streamline Clinical Trials With Intuitive And Efficient Data Management Solutions
Pros
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Purpose-built for clinical trials, not a generic database adaptation
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Audit trails meet FDA 21 CFR Part 11 compliance out-of-the-box
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Open-source version gives smaller research teams a cost-effective entry point
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Data capture forms handle complex branching logic without custom coding
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Electronic data capture and randomization live within one unified platform
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Regulatory-grade security makes it a realistic choice for pharma studies
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Study build tools let coordinators configure protocols without deep IT support
Cons
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Configuring complex study designs demands significant technical expertise upfront
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Reporting tools feel limited for teams needing deeper clinical insights
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Open-source version requires dedicated IT resources to maintain and host
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Pricing structure becomes harder to justify for smaller research teams
Editorial Buyer Guidance
Who Is OpenClinica Best For?
Review the buyer problem, target users, practical use cases, and product differentiator identified by the SoftwareWorld review team.
Problem It Solves
Streamlines Clinical Trial Data Management And Compliance For ResearchersTarget Users
- Clinical Researchers
- Data Managers
- Study Coordinators
- Principal Investigators
- Regulatory Professionals
Core Use Cases
- Collect Clinical Trial Data
- Manage Study Participants
- Monitor Study Progress
- Ensure Data Compliance
- Generate Study Reports
Unique Selling Point
Streamline Clinical Trials With Intuitive And Efficient Data Management Solutions
Strengths and Limitations
OpenClinica Pros & Cons
Consider the practical advantages and limitations identified through SoftwareWorld's product assessment.
+
Pros
- Purpose-built for clinical trials, not a generic database adaptation
- Audit trails meet FDA 21 CFR Part 11 compliance out-of-the-box
- Open-source version gives smaller research teams a cost-effective entry point
- Data capture forms handle complex branching logic without custom coding
- Electronic data capture and randomization live within one unified platform
- Regulatory-grade security makes it a realistic choice for pharma studies
- Study build tools let coordinators configure protocols without deep IT support
!
Cons
- Configuring complex study designs demands significant technical expertise upfront
- Reporting tools feel limited for teams needing deeper clinical insights
- Open-source version requires dedicated IT resources to maintain and host
- Pricing structure becomes harder to justify for smaller research teams
Sponsored Products
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Sponsored placements are paid positions and do not influence OpenClinica profile information, SoftwareWorld’s editorial assessment, or user reviews.
Category-Based Capabilities
OpenClinica Features
Each category combines the selected software category, its category-specific description, and the features assigned to that category.
Clinical Trial Management Software 26 selected features Open category ↗ ⌄
Clinical Study Management
Reporting & Statistics
Role-Based Permissions
Progress Tracking
Audit Trail
Data Visualization
Electronic Data Capture
Document Management
Alerts/Notifications
EMR/EHR
Inventory Management
Forms Management
User Management
HIPAA Compliant
Patient Monitoring
Data Verification
Enrollments/Onboarding
Ad hoc Reporting
Trial Design
Patient Recruiting
Audit Management
Digital Signature
Financial Management
Patient Management
Access Controls/Permissions
Compliance Management
Data Entry Software 11 selected features Open category ↗ ⌄
Optical Character Recognition
Data Import/Export
Document Management
Image Capture
Data Replication
Phonetic Variation Detection
Mis-Keyed Variation Detection
Task Management
Customizable Forms
Data Quality Control
Abbreviation Detection
Electronic Data Capture Software 12 selected features Open category ↗ ⌄
Remote Data Capture
Reporting/Analytics
Clinical Study Management
Data Import/Export
Document Classification
Third-Party Integrations
Compliance Management
Distributed Capture
CRF Tracking
Audit Trail
Document Imaging
Forms Management
Connected Applications
OpenClinica Integrations
Integration information is displayed only when approved integration products are available on the profile.
Microsoft Power BI
AWS Cloud
Microsoft Azure
Salesforce Sales Cloud
Google Cloud
Tableau
Zapier
LabVantage
Medidata CTMS
Pricing Information
OpenClinica Pricing
Pricing type, currency, trial availability, payment frequency, destination links, and package-level starting prices.
Verified User Feedback
Write a OpenClinica Review ↗
OpenClinica Reviews
Approved reviews submitted through verified Google or LinkedIn reviewer accounts.
Francesco L.
Head of Clinical Data Systems
Comprehensive and Supportive Clinical Data Platform
Our experience with OpenClinica has been very positive. It’s a comprehensive system that adapts well to most data capture needs. The interface is easy to use, and the drag-and-drop design makes creating forms simple even for less technical users. Support is responsive and helpful, and user feedback is genuinely considered for future updates. While customization of user roles and permissions can feel a bit limited, and some additional modules or professional services can be pricey in an academic setting, overall it’s a reliable and effective platform for complex projects across time zones.
Reviewed on February, 2024
Krister K.
CTO
Trusted and Powerful Clinical Study Platform
I’ve been working with OpenClinica for over 15 years and have loved seeing how it has evolved. Setting up new studies is straightforward, and the management functions are very effective. I can’t think of any drawbacks—having worked with clinical studies my entire career and used many tools, OpenClinica has consistently addressed all our needs.
Reviewed on February, 2024
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Frequently Asked Questions
OpenClinica FAQs
Answers generated from approved profile information, selected options, packages, integrations, support, training, deployment, and devices.
OpenClinica is an innovative software designed for streamlining clinical research and data management. Known for its flexibility and user-friendly interface, it greatly simplifies the process of collecting and managing clinical trial data. OpenClinica excels in offering robust features like electronic data capture, patient engagement tools, and comprehensive data reporting. It supports easy creation and customization of forms, ensuring precise data collection tailored to specific study requirements. The software's real-time data validation feature enhances accuracy and consistency. OpenClinica is also highly secure, ensuring the protection of sensitive patient data. Its capability for seamless integration with other systems makes it a versatile choice for researchers and healthcare professionals looking for an efficient and reliable clinical trial management solution.
- No, OpenClinica does not offer a free version.
- Yes, OpenClinica offers a free trial.
- No, Credit Card details are not required for the OpenClinica trial.
- No, OpenClinica does not offer an API.
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OpenClinica can be integrated with the following applications:
- Salesforce Sales Cloud , Tableau , Microsoft Power BI , AWS Cloud , Google Cloud , Zapier , Microsoft Azure , Medidata CTMS , LabVantage , RedCap
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OpenClinica offers support with the following options:
- 24x7 Support , Email , Phone , Chat , Knowledge Base
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OpenClinica offers training with the following options:
- In-person , Webinar , Documentation
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OpenClinica supports the following languages:
- English
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Following are the typical users of the OpenClinica:
- Small-Business , Midsize-Business , Large-Enterprise-Business
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OpenClinica supports the following deployment:
- Cloud Hosted , On-Premise
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OpenClinica supports the following devices and operating systems:
- Web-Based , Windows , Linux
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