The two tables below compare and contrast the Community, Enterprise (OC3.x), and new (OC4) versions of OpenClinica. The first table summarizes those differences, while the second provides a feature-by-feature comparison. We hope you recognize your challenges and their solutions in the tables below. Don’t hesitate to contact us for guidance.
Please note that we are not able to offer any support or services for our free, community-edition EDC. It is the user’s full responsibility to download, implement, integrate and validate the software.
| Edition | Advantages | Considerations |
|---|---|---|
| Community (Get started here) |
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| Enterprise |
| Our software-as-a-service offering requires a low set-up fee and monthly subscription. Note that the Community-related costs of self-hosting, validation, augmentation with ePRO and IxRS, and internal support can exceed the expense of Software-as-a-Service. |
| OC4 | All of the Enterprise features, plus…
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| Function | Feature | Community | OC 3 Enterprise | OC 4 Enterprise |
|---|---|---|---|---|
| Study Design | Collaborative, drag-and-drop study designer |  |
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| Study Design | Fully functional form previews | |
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| Study Design | One-click publishing to test and production | |
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| Users and Organizations | Unlimited users and sites | | | |
| Users and Organizations | Easily select existing users and sites for a new study | |
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| Form functionality | Capable form authoring environment | Basic | Basic | Advanced |
| Form functionality | Rule Designer | | |
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| Form functionality | Real-time edit checks | |
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| Form functionality | Cross form checks, calculations, and dynamic logic part defined conveniently within form | |
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| Form functionality | Queries fire automatically on unresolved edit checks | | | |
| Form functionality | Reason for Change | | | |
| Form layout | Multi-page | | | |
| Form layout | Mobile friendly | Participant-facing forms only | All forms | |
| Form layout | Multiple style options | |
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| Form items | Radio buttons, text, numeric values, picklists | | | |
| Form items | Cascading picklists | |
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| Form items | Likert scales | |
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| Form items | Real-time calculations/scoring | |
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| Form items | Note fields | Participant-facing forms | All forms | |
| Form items | Visual analog scales | Participant-facing forms | All forms | |
| Form items | Images as selections | |
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| Form items | Upload files/images | Small files | Small files | Large files |
| Form items | Drawing | |
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| Form items | Clickable image maps | |
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| Form items | Auto-complete | |
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| ePRO / eCOA | Capture diaries, surveys, outcomes measures directly from study participants on ANY device | | |
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| ePRO / eCOA | Engage study participants on their own devices | | |
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| ePRO / eCOA | Automate notifications via text message and email | | |
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| ePRO / eCOA | Capture data offline | | |
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| ePRO / eCOA | EDC and ePRO data in one place | | |
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| Reporting | Interactive visual reports | | |
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| Reporting | Report against all data and metadata (clinical data, ePRO, operational data, audit log data, query data, SDV data, and more) | | |
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| Reporting | Custom dashboards | | |
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| Reporting | Custom user roles to control data access | | |
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| Reporting | Automatically push report updates via email or Slack | | |
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| Reporting | Direct access to data warehouse | | |
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| Randomization and Supply Management | Randomize from within OpenClinica eCRFs | | |
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| Randomization and Supply Management | Blinded or unblinded | | |
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| Randomization and Supply Management | Stratify on any variable | | |
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| Randomization and Supply Management | Codelist management | | |
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| Randomization and Supply Management | Manage investigational supplies | | |
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| Randomization and Supply Management | Reporting and auto-notifications | | |
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| Compliance | Compliant with 21 CFR Part 11, ICH GCP, Annex 11, HIPAA, GDPR | | |
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| Compliance | Validation of Installations and Upgrades (IQ/OQ/PQ) | | |
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| Compliance | Access to the OpenClinica Quality System (SOPs, software requirement specifications, traceability matrices, release plans and summary reports, cloud security and validation artifacts, and more) | | |
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| Compliance | Access to OpenClinica's Compliance Team (regulatory questions/interpretations, best practice guidance, UAT strategies and techniques, audit requests) | | |
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| Compliance | Regional data hosting options | | |
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| Security, Reliability, and Performance | Full data encryption at rest and in transit | | |
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| Security, Reliability, and Performance | Zero data loss architecture | | |
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| Security, Reliability, and Performance | Ongoing vulnerability and penetration testing (OWASP) | | |
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| Security, Reliability, and Performance | High availabilty configuration of key components; minimize single points of failure | |
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| Security, Reliability, and Performance | FedRAMP / FISMA | | |
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| Security, Reliability, and Performance | Architected for the cloud | |
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| Security, Reliability, and Performance | Validated disaster recovery and business continuity plans | | |
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| Security, Reliability, and Performance | Monitored 24/7/365 | | |
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| Extensibility | API | Basic | Basic | Enhanced |
| Extensibility | Integrations with third party systems | | |
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| Assuring your success | Access to user forums and documentation | | | |
| Assuring your success | Dedicated Software Support | | |
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| Assuring your success | Implementation success programs | | |
