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OpenClinica
Needham, Massachusetts, USA
What it is
OpenClinica is an eClinical platform for electronic data capture, eConsent, eCOA, randomization, EHR-to-EDC, analytics, and patient recruitment. Its EDC tools include drag-and-drop study building, templated CRFs, and real-time validation. EHR-to-EDC connects systems such as Epic and Cerner through FHIR or HL7, bringing clinical source data into study forms; described data includes vitals, labs, medications, and medical history, with coordinator review and audit trails. The company says the platform complies with ICH GCP E6 (R2), 21 CFR Part 11, HIPAA, and GDPR, and is SOC 2 Type II and ISO 27001 certified. Launch costs $750 a month and includes a 30-day free trial; it is EDC-only and limited to 150 participants and three sites, with email notifications only and no API or SMS. Core costs $3,000 a month per study on a 12-month contract, while Advanced costs $3,750 a month per study on that term. A free, open-source Community Edition is available under GNU LGPL. Enterprise is offered cloud-hosted or self-hosted and managed.
For and against
For
- EDC includes drag-and-drop study building and templated CRFs.
- EHR-to-EDC supports FHIR or HL7 connections.
- The company states multiple compliance standards and certifications.
- Community Edition is free and open source.
- Every client gets onboarding and a Customer Success Manager.
Against
- Launch costs $750 a month.
- Launch is limited to 150 participants and three sites.
- Launch has email notifications only, with no API or SMS.
- Core and Advanced require 12-month contracts.
The verdict
OpenClinica combines study data capture with related clinical research tools and EHR connections. Compare plan limits and contract terms, or consider the free Community Edition, before choosing an offering.
Who it suits
The company says it focuses on small to midsize sponsors, CROs, and academic research teams. The range of plans and deployment options may suit teams with different study and hosting needs.
Plans and prices
Launch
EDC only · 30-day free trial · 150 participants · 3 sites
Read 14 Oct 2026 · openclinica.com
Core
EDC, reporting and analytics · advanced analytics · API access · workflows and SMS
Read 14 Oct 2026 · openclinica.com
Advanced
Core plus one module · 3+ concurrent studies · unlimited data · MFA and SSO
Read 14 Oct 2026 · openclinica.com
Enterprise & Academic
20+ studies · no data limits · all modules unlocked program-wide · enterprise analytics
Read 14 Oct 2026 · openclinica.com
On the record
- API
- The service exposes REST web services for data exchange and bulk imports, event scheduling and participant creation.servicedesk.openclinica.com · read 14 Oct 2026
- API limitation
- Launch subscriptions do not include API access; Core and higher plans do.servicedesk.launch.openclinica.com · read 14 Oct 2026
- API tooling
- An authenticated Swagger interface lets administrators inspect and execute API endpoints; documented operations include JSON, XML or PDF retrieval, XML import, participant and site creation.servicedesk.openclinica.com · read 14 Oct 2026
- Browser support
- Supported desktop browsers are current Chrome, Edge, Firefox and Safari; Chrome is supported on Android and Safari on iOS/iPadOS, while IE11 and Edge Legacy are unsupported.openclinica.helpscoutdocs.com · read 14 Oct 2026
- Community download
- The latest listed Community Edition release is OpenClinica 3.17.3 dated 12 November 2025; a separate web-services package is available for SOAP use.docs.openclinica.com · read 14 Oct 2026
- Community edition
- OpenClinica offers a free, open-source Community Edition distributed under the GNU LGPL license.docs.openclinica.com · read 7 Oct 2026
- Company founders
- OpenClinica identifies Cal Collins and Ben Baumann as co-founders.openclinica.com · read 14 Oct 2026
- Company founding
- LinkedIn lists OpenClinica as founded in 2004.linkedin.com · read 14 Oct 2026
- Company headquarters and size
- LinkedIn lists OpenClinica as privately held, headquartered in Waltham, Massachusetts, with 51–200 employees.linkedin.com · read 14 Oct 2026
- Company history
- The company says it has spent 20 years building eClinical software and that its EDC began for academic institutions.openclinica.com · read 7 Oct 2026
- Compliance
- The company states its platform is ICH GCP E6 (R2), 21 CFR Part 11, HIPAA, and GDPR compliant, and SOC 2 Type II and ISO 27001 certified.openclinica.com · read 7 Oct 2026
- Deployment
- OpenClinica documentation says its Enterprise offering is available as a cloud-hosted solution or a self-hosted and managed system.docs.openclinica.com · read 7 Oct 2026
- Documentation
- OpenClinica publishes user, technical/API and Participate guides plus a searchable support knowledge base.openclinica.com · read 14 Oct 2026
- eCOA
- The eCOA module lets participants complete mobile-friendly assessments with media, visual scales and automated reminders without installing an app.openclinica.com · read 14 Oct 2026
- eConsent
- Its consent module supports multimedia consent, comprehension checks, notifications and electronic signatures for remote, in-person or hybrid studies.openclinica.com · read 14 Oct 2026
- EDC features
- Its EDC offering includes drag-and-drop study building, templated CRFs, and real-time validation.openclinica.com · read 7 Oct 2026
- EDC study builder
- The platform provides drag-and-drop study design, templated case-report forms and real-time validation.openclinica.com · read 14 Oct 2026
- EHR integration
- The EHR-to-EDC module uses FHIR and HL7 to move data from systems such as Epic and Cerner into study forms with review and audit trails.openclinica.com · read 14 Oct 2026
