OpenClinica

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.

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.

Summary of Differences

EditionAdvantagesConsiderations
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

FunctionFeatureCommunityOC 3
Enterprise		OC 4
Enterprise
Study DesignCollaborative, drag-and-drop study designer
Study DesignFully functional form previews
Study DesignOne-click publishing to test and production
Users and OrganizationsUnlimited users and sites
Users and OrganizationsEasily select existing users and sites for a new study
Form functionalityCapable form authoring environmentBasicBasicAdvanced
Form functionalityRule Designer
Form functionalityReal-time edit checks
Form functionalityCross form checks, calculations, and dynamic logic part defined conveniently within form
Form functionalityQueries fire automatically on unresolved edit checks
Form functionalityReason for Change
Form layoutMulti-page
Form layoutMobile friendlyParticipant-facing forms onlyAll forms
Form layoutMultiple style options
Form itemsRadio buttons, text, numeric values, picklists
Form itemsCascading picklists
Form itemsLikert scales
Form itemsReal-time calculations/scoring
Form itemsNote fieldsParticipant-facing formsAll forms
Form itemsVisual analog scalesParticipant-facing formsAll forms
Form itemsImages as selections
Form itemsUpload files/imagesSmall filesSmall filesLarge files
Form itemsDrawing
Form itemsClickable image maps
Form itemsAuto-complete
ePRO / eCOACapture diaries, surveys, outcomes measures directly from study participants on ANY device
ePRO / eCOAEngage study participants on their own devices
ePRO / eCOAAutomate notifications via text message and email
ePRO / eCOACapture data offline
ePRO / eCOAEDC and ePRO data in one place
ReportingInteractive visual reports
ReportingReport against all data and metadata (clinical data, ePRO, operational data, audit log data, query data, SDV data, and more)
ReportingCustom dashboards
ReportingCustom user roles to control data access
ReportingAutomatically push report updates via email or Slack
ReportingDirect access to data warehouse
Randomization and Supply ManagementRandomize from within OpenClinica eCRFs
Randomization and Supply ManagementBlinded or unblinded
Randomization and Supply ManagementStratify on any variable
Randomization and Supply ManagementCodelist management
Randomization and Supply ManagementManage investigational supplies
Randomization and Supply ManagementReporting and auto-notifications
ComplianceCompliant with 21 CFR Part 11, ICH GCP, Annex 11, HIPAA, GDPR
ComplianceValidation of Installations and Upgrades (IQ/OQ/PQ)
ComplianceAccess to the OpenClinica Quality System (SOPs, software requirement specifications, traceability matrices, release plans and summary reports, cloud security and validation artifacts, and more)
ComplianceAccess to OpenClinica's Compliance Team (regulatory questions/interpretations, best practice guidance, UAT strategies and techniques, audit requests)
ComplianceRegional data hosting options
Security, Reliability, and PerformanceFull data encryption at rest and in transit
Security, Reliability, and PerformanceZero data loss architecture
Security, Reliability, and PerformanceOngoing vulnerability and penetration testing (OWASP)
Security, Reliability, and PerformanceHigh availabilty configuration of key components; minimize single points of failure
Security, Reliability, and PerformanceFedRAMP / FISMA
Security, Reliability, and PerformanceArchitected for the cloud
Security, Reliability, and PerformanceValidated disaster recovery and business continuity plans
Security, Reliability, and PerformanceMonitored 24/7/365
ExtensibilityAPIBasicBasicEnhanced
ExtensibilityIntegrations with third party systems
Assuring your successAccess to user forums and documentation
Assuring your successDedicated Software Support
Assuring your successImplementation success programs