Community, OC3, and OC4: What’s the Difference?
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.
Summary of Differences
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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Feature Comparison
Function | Feature | Community | OC 3 Enterprise | OC 4 Enterprise |
---|---|---|---|---|
Study Design | Collaborative, drag-and-drop study designer | ![]() | ||
Study Design | Fully functional form previews | ![]() | ||
Study Design | One-click publishing to test and production | ![]() | ||
Users and Organizations | Unlimited users and sites | ![]() | ![]() | ![]() |
Users and Organizations | Easily select existing users and sites for a new study | ![]() | ||
Form functionality | Capable form authoring environment | Basic | Basic | Advanced |
Form functionality | Rule Designer | ![]() | ![]() | |
Form functionality | Real-time edit checks | ![]() | ||
Form functionality | Cross form checks, calculations, and dynamic logic part defined conveniently within form | ![]() | ||
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 | ![]() | ||
Form items | Radio buttons, text, numeric values, picklists | ![]() | ![]() | ![]() |
Form items | Cascading picklists | ![]() | ||
Form items | Likert scales | ![]() | ||
Form items | Real-time calculations/scoring | ![]() | ||
Form items | Note fields | Participant-facing forms | All forms | |
Form items | Visual analog scales | Participant-facing forms | All forms | |
Form items | Images as selections | ![]() | ||
Form items | Upload files/images | Small files | Small files | Large files |
Form items | Drawing | ![]() | ||
Form items | Clickable image maps | ![]() | ||
Form items | Auto-complete | ![]() | ||
ePRO / eCOA | Capture diaries, surveys, outcomes measures directly from study participants on ANY device | ![]() | ![]() | |
ePRO / eCOA | Engage study participants on their own devices | ![]() | ![]() | |
ePRO / eCOA | Automate notifications via text message and email | ![]() | ![]() | |
ePRO / eCOA | Capture data offline | ![]() | ![]() | |
ePRO / eCOA | EDC and ePRO data in one place | ![]() | ![]() | |
Reporting | Interactive visual reports | ![]() | ![]() | |
Reporting | Report against all data and metadata (clinical data, ePRO, operational data, audit log data, query data, SDV data, and more) | ![]() | ![]() | |
Reporting | Custom dashboards | ![]() | ![]() | |
Reporting | Custom user roles to control data access | ![]() | ![]() | |
Reporting | Automatically push report updates via email or Slack | ![]() | ![]() | |
Reporting | Direct access to data warehouse | ![]() | ![]() | |
Randomization and Supply Management | Randomize from within OpenClinica eCRFs | ![]() | ![]() | |
Randomization and Supply Management | Blinded or unblinded | ![]() | ![]() | |
Randomization and Supply Management | Stratify on any variable | ![]() | ![]() | |
Randomization and Supply Management | Codelist management | ![]() | ![]() | |
Randomization and Supply Management | Manage investigational supplies | ![]() | ![]() | |
Randomization and Supply Management | Reporting and auto-notifications | ![]() | ![]() | |
Compliance | Compliant with 21 CFR Part 11, ICH GCP, Annex 11, HIPAA, GDPR | ![]() | ![]() | |
Compliance | Validation of Installations and Upgrades (IQ/OQ/PQ) | ![]() | ![]() | |
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) | ![]() | ![]() | |
Compliance | Access to OpenClinica's Compliance Team (regulatory questions/interpretations, best practice guidance, UAT strategies and techniques, audit requests) | ![]() | ![]() | |
Compliance | Regional data hosting options | ![]() | ![]() | |
Security, Reliability, and Performance | Full data encryption at rest and in transit | ![]() | ![]() | |
Security, Reliability, and Performance | Zero data loss architecture | ![]() | ![]() | |
Security, Reliability, and Performance | Ongoing vulnerability and penetration testing (OWASP) | ![]() | ![]() | |
Security, Reliability, and Performance | High availabilty configuration of key components; minimize single points of failure | ![]() | ||
Security, Reliability, and Performance | FedRAMP / FISMA | ![]() | ![]() | |
Security, Reliability, and Performance | Architected for the cloud | ![]() | ||
Security, Reliability, and Performance | Validated disaster recovery and business continuity plans | ![]() | ![]() | |
Security, Reliability, and Performance | Monitored 24/7/365 | ![]() | ![]() | |
Extensibility | API | Basic | Basic | Enhanced |
Extensibility | Integrations with third party systems | ![]() | ![]() | |
Assuring your success | Access to user forums and documentation | ![]() | ![]() | ![]() |
Assuring your success | Dedicated Software Support | ![]() | ![]() | |
Assuring your success | Implementation success programs | ![]() | ![]() |