OpenClinica Unite

JSON twin: https://www.healthaidb.com/software/openclinica-unite.json

Company Name

OpenClinica

Product URL

https://www.openclinica.com/unite-ehr-esource-2/

Company URL

https://www.openclinica.com

Categories

• clinical Care
• clinical Data Collection
• ehr Integration
• clinical Research
• data Integration
• regulatory Compliance
• Clinical
• Electronic Data Capture
• Esource
• Research

Summary

OpenClinica Unite is an integrated EHR-to-EDC eSource solution that automates the transfer of clinical data from electronic health records to clinical trial databases, enhancing data quality and accelerating research timelines.

Description

OpenClinica Unite streamlines clinical trials by automating the extraction of patient data from EHRs into EDCs and eCRFs, reducing manual transcription errors and improving data quality. It supports compliance with GCP and 21 CFR Part 11, integrates seamlessly with major EHR systems like Epic and Cerner, and offers scalability across multiple sites and health systems. The solution also facilitates the inclusion of diverse data sources, including medical devices and wearables, to enhance study outcomes.

Api Available

yes

Certifications

• SOC 2

Company Founding

2004

Company Offices

• United States
• United Kingdom
• Germany
• India
• China
• Japan
• Australia
• Brazil
• South Africa
• Singapore

Compliance

• FDA 21 CFR Part 11
• HIPAA
• GDPR

Customers

• OpenClinica Enterprise Edition

Data Residency

SaaS-hosted; lightweight site-side footprint with no client software to install; leverages SMART on FHIR-capable EHRs

Data Standards

• SMART on FHIR
• FHIR
• HL7
• CDISC

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• EHR to EDC eSource data capture
• SMART on FHIR launch from EHR chart
• Automatic population of eCRFs from EHR
• Traceability to source (data originator, element identifiers)
• Real-time / near‑real‑time data access
• Data summaries, trends and visualizations
• Reduced source data verification (SDV) impact
• Site workflow integration (launch within patient chart)
• Scalable network across sites and health systems
• Support for medical device/wearable data ingestion
• Standards-based, lightweight implementation
• Multi‑study / multi‑sponsor reuse

Id

SW1933

Integration Partners

• Medrio EDC
• Castor
• REDCap
• Oracle Clinical

Integrations

• Epic EHR
• Cerner EHR
• Apple Health

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Unite network/site onboarding services
• Site standardization/harmonization services
• Professional services: study configuration, migration, integration, training

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• GDPR support
• HIPAA-aligned controls
• Traceability to data originator
• Customer reviewable compliance/security artifacts (BAA available on request)

Product Code

SW1933

Product Name

OpenClinica Unite

Ratings

• 4.2 out of 5 stars on G2
• 4.3 out of 5 stars on G2
• 4.6 out of 5 stars on G2

Regions Available

• United States
• Canada
• European Union
• United Kingdom
• Australia
• New Zealand
• India
• China
• Japan
• South Korea
• Brazil
• Mexico
• South Africa
• Russia
• Saudi Arabia
• United Arab Emirates
• Singapore
• Malaysia
• Thailand
• Indonesia

Related Urls

• https://elion.health/products/openclinica-unite

Release Year

2004

Security Features

• Encryption (in transit and at rest)
• Role-based access control (RBAC)
• SSO/SAML support
• Audit logs / audit trail
• Comprehensive information security program

Specialties

• Clinical Trials
• Data Management
• Healthcare It
• Regulatory Compliance

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

SaaS-hosted; lightweight site-side footprint with no client software to install; leverages SMART on FHIR-capable EHRs

Target Users

• clinical research coordinators
• clinical research associates
• data managers
• study sponsors
• healthcare IT professionals

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The SuperUser Training they offer is one of the most helpful things they offer, as well as their support. It's easy to setup once you learn how to do it. Cost is a plus too!
• Very easy to create and update forms. Great customer support. Quick to learn and user friendly.
• The support provided by the Openclinica team cannot be beat. If I may list two things, the OC system is incredibly user friendly.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "OpenClinica Unite",
  "company_name": "OpenClinica",
  "product_url": "https://www.openclinica.com/unite-ehr-esource-2/",
  "company_url": "https://www.openclinica.com",
  "related_urls": [
    "https://elion.health/products/openclinica-unite"
  ],
  "product_code": "SW1933",
  "summary": "OpenClinica Unite is an integrated EHR-to-EDC eSource solution that automates the transfer of clinical data from electronic health records to clinical trial databases, enhancing data quality and accelerating research timelines.",
  "description": "OpenClinica Unite streamlines clinical trials by automating the extraction of patient data from EHRs into EDCs and eCRFs, reducing manual transcription errors and improving data quality. It supports compliance with GCP and 21 CFR Part 11, integrates seamlessly with major EHR systems like Epic and Cerner, and offers scalability across multiple sites and health systems. The solution also facilitates the inclusion of diverse data sources, including medical devices and wearables, to enhance study outcomes.",
  "categories": [
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    "clinical Data Collection",
    "ehr Integration",
    "clinical Research",
    "data Integration",
    "regulatory Compliance",
    "Clinical",
    "Electronic Data Capture",
    "Esource",
    "Ehr Integration",
    "Research",
    "Data Integration",
    "Regulatory Compliance"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinical research coordinators",
    "clinical research associates",
    "data managers",
    "study sponsors",
    "healthcare IT professionals"
  ],
  "specialties": [
    "Clinical Trials",
    "Data Management",
    "Healthcare It",
    "Regulatory Compliance"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "European Union",
    "United Kingdom",
    "Australia",
    "New Zealand",
    "India",
    "China",
    "Japan",
    "South Korea",
    "Brazil",
    "Mexico",
    "South Africa",
    "Russia",
    "Saudi Arabia",
    "United Arab Emirates",
    "Singapore",
    "Malaysia",
    "Thailand",
    "Indonesia"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Germany",
    "India",
    "China",
    "Japan",
    "Australia",
    "Brazil",
    "South Africa",
    "Singapore"
  ],
  "company_founding": "2004",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "EHR to EDC eSource data capture",
    "SMART on FHIR launch from EHR chart",
    "Automatic population of eCRFs from EHR",
    "Traceability to source (data originator, element identifiers)",
    "Real-time / near‑real‑time data access",
    "Data summaries, trends and visualizations",
    "Reduced source data verification (SDV) impact",
    "Site workflow integration (launch within patient chart)",
    "Scalable network across sites and health systems",
    "Support for medical device/wearable data ingestion",
    "Standards-based, lightweight implementation",
    "Multi‑study / multi‑sponsor reuse"
  ],
  "optional_modules": [
    "Unite network/site onboarding services",
    "Site standardization/harmonization services",
    "Professional services: study configuration, migration, integration, training"
  ],
  "integrations": [
    "Epic EHR",
    "Cerner EHR",
    "Apple Health"
  ],
  "data_standards": [
    "SMART on FHIR",
    "FHIR",
    "HL7",
    "CDISC"
  ],
  "api_available": "yes",
  "system_requirements": "SaaS-hosted; lightweight site-side footprint with no client software to install; leverages SMART on FHIR-capable EHRs",
  "compliance": [
    "FDA 21 CFR Part 11",
    "HIPAA",
    "GDPR"
  ],
  "certifications": [
    "SOC 2"
  ],
  "security_features": [
    "Encryption (in transit and at rest)",
    "Role-based access control (RBAC)",
    "SSO/SAML support",
    "Audit logs / audit trail",
    "Comprehensive information security program"
  ],
  "privacy_features": [
    "GDPR support",
    "HIPAA-aligned controls",
    "Traceability to data originator",
    "Customer reviewable compliance/security artifacts (BAA available on request)"
  ],
  "data_residency": "SaaS-hosted; lightweight site-side footprint with no client software to install; leverages SMART on FHIR-capable EHRs",
  "customers": [
    "OpenClinica Enterprise Edition"
  ],
  "user_reviews": [
    "The SuperUser Training they offer is one of the most helpful things they offer, as well as their support. It's easy to setup once you learn how to do it. Cost is a plus too!",
    "Very easy to create and update forms. Great customer support. Quick to learn and user friendly.",
    "The support provided by the Openclinica team cannot be beat. If I may list two things, the OC system is incredibly user friendly."
  ],
  "ratings": [
    "4.2 out of 5 stars on G2",
    "4.3 out of 5 stars on G2",
    "4.6 out of 5 stars on G2"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2004",
  "integration_partners": [
    "Medrio EDC",
    "Castor",
    "REDCap",
    "Oracle Clinical"
  ],
  "id": "SW1933",
  "slug": "openclinica-unite",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/openclinica-unite.json"
  }
}