What's the difference? » OpenClinica

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)	No set-up or subscription fees Unlimited users, sites, and forms	Stand alone EDC Basic forms Not validated Must be hosted on your own server No dedicated support
Enterprise	Validated Compliance support included Cloud hosted for maximum security, reliability, and performance Easy addition of ePRO, IxRS, supply management, and reporting modules Robust integration with other common eClinical platforms (e.g. CTMS, biospecimen tracking) Dedicated user support	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… A collaborative, drag-and-drop study designer Ultra-capable forms engine supporting real-time edit checks, powerful skip logic, reason for change workflow, and auto-save Flexible form layout UI-optimized form items that include Likert scales, visual analog scales, images as selection choices, clickable image maps, large file uploads, and more

Edition

Advantages

Considerations

Community
(Get started here)

No set-up or subscription fees
Unlimited users, sites, and forms

Stand alone EDC
Basic forms
Not validated
Must be hosted on your own server
No dedicated support

Enterprise

Validated
Compliance support included
Cloud hosted for maximum security, reliability, and performance
Easy addition of ePRO, IxRS, supply management, and reporting modules
Robust integration with other common eClinical platforms (e.g. CTMS, biospecimen tracking)
Dedicated user support

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…

A collaborative, drag-and-drop study designer
Ultra-capable forms engine supporting real-time edit checks, powerful skip logic, reason for change workflow, and auto-save
Flexible form layout
UI-optimized form items that include Likert scales, visual analog scales, images as selection choices, clickable image maps, large file uploads, and more

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

Community, OC3, and OC4: What’s the Difference?

Summary of Differences

Feature Comparison

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