OpenClinica

Spec sheet

What it does

OpenClinica is an electronic data capture and clinical data-management platform for building and running clinical studies.Read 14 Oct 2026 · github.com

Product

OpenClinica is an eClinical platform combining electronic data capture, eConsent, eCOA, randomization, EHR-to-EDC, analytics, and patient recruitment.Read 7 Oct 2026 · openclinica.com

Intended users

The company says it focuses on small to midsize sponsors, CROs, and academic research teams.Read 7 Oct 2026 · openclinica.com

Deployment

OpenClinica documentation says its Enterprise offering is available as a cloud-hosted solution or a self-hosted and managed system.Read 7 Oct 2026 · docs.openclinica.com

API

The service exposes REST web services for data exchange and bulk imports, event scheduling and participant creation.Read 14 Oct 2026 · servicedesk.openclinica.com

Integrations

The product advertises standards-based EHR connectivity, Apple Health collection and links to common clinical-research systems such as CTMS, labs, payments and IxRS through integrations or APIs.Read 14 Oct 2026 · openclinica.com

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.Read 7 Oct 2026 · openclinica.com

Support

Commercial support is advertised as available 24 hours a day, five days a week on weekdays, with ticketing and telephone access.Read 14 Oct 2026 · openclinica.com

Headquarters

Needham, Massachusetts, USARead 28 Sep 2026 · openclinica.com

API limitation

Launch subscriptions do not include API access; Core and higher plans do.Read 14 Oct 2026 · servicedesk.launch.openclinica.com

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.Read 14 Oct 2026 · servicedesk.openclinica.com

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.Read 14 Oct 2026 · openclinica.helpscoutdocs.com

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.Read 14 Oct 2026 · docs.openclinica.com

Community edition

OpenClinica offers a free, open-source Community Edition distributed under the GNU LGPL license.Read 7 Oct 2026 · docs.openclinica.com

Company founders

OpenClinica identifies Cal Collins and Ben Baumann as co-founders.Read 14 Oct 2026 · openclinica.com

Company founding

LinkedIn lists OpenClinica as founded in 2004.Read 14 Oct 2026 · linkedin.com

Company headquarters and size

LinkedIn lists OpenClinica as privately held, headquartered in Waltham, Massachusetts, with 51–200 employees.Read 14 Oct 2026 · linkedin.com

Company history

The company says it has spent 20 years building eClinical software and that its EDC began for academic institutions.Read 7 Oct 2026 · openclinica.com

Documentation

OpenClinica publishes user, technical/API and Participate guides plus a searchable support knowledge base.Read 14 Oct 2026 · openclinica.com

eCOA

The eCOA module lets participants complete mobile-friendly assessments with media, visual scales and automated reminders without installing an app.Read 14 Oct 2026 · openclinica.com

eConsent

Its consent module supports multimedia consent, comprehension checks, notifications and electronic signatures for remote, in-person or hybrid studies.Read 14 Oct 2026 · openclinica.com

EDC features

Its EDC offering includes drag-and-drop study building, templated CRFs, and real-time validation.Read 7 Oct 2026 · openclinica.com

EDC study builder

The platform provides drag-and-drop study design, templated case-report forms and real-time validation.Read 14 Oct 2026 · openclinica.com

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.Read 14 Oct 2026 · openclinica.com

FedRAMP status

The company says five services are in its FedRAMP certification work boundary and that its FedRAMP identifier is still pending.Read 14 Oct 2026 · openclinica.com

Free study build

OpenClinica says its Core, Advanced, and Enterprise & Academic plans include a free expert-managed study build.Read 7 Oct 2026 · openclinica.com

Launch plan limit

Launch is EDC-only and limited to 150 participants and three sites, with email notifications only and no API or SMS.Read 7 Oct 2026 · openclinica.com

Limit: cost

Reviewers describe extra modules, professional services and the overall product as expensive for some small hospitals or academic organizations.Read 14 Oct 2026 · capterra.com

Limit: permissions

Reviewers report that role and permission customization can be too restricted, including difficulty limiting access to individual form sections.Read 14 Oct 2026 · softwareadvice.com

Limit: scheduling

A reviewer says automatic scheduling is limited, although an update was expected.Read 14 Oct 2026 · softwareadvice.com

Limit: support and reliability

Independent reviews mention occasional slow support, difficult testing of invitations, browser compatibility problems and performance concerns with large or complex studies.Read 14 Oct 2026 · softwareadvice.com

Notable news: 2026 release

OpenClinica 4 Stack 20.2 was released on 25 July 2026 and renamed modules including Unite to EHR-to-EDC, Insight to Reporting and Analytics, Randomize to Randomization and Participate to eCOA.Read 14 Oct 2026 · servicedesk.launch.openclinica.com

Open-source licence

The Community Edition is free, open source and distributed under the GNU LGPL licence.Read 14 Oct 2026 · docs.openclinica.com

Other EHR data

The EHR-to-EDC page describes collecting vitals, labs, medications, and medical history with coordinator review and audit trails.Read 7 Oct 2026 · openclinica.com

Praise: usability and support

Independent reviewers repeatedly praise the intuitive interface, easy form creation, helpful support staff and ability to handle complex study designs.Read 14 Oct 2026 · g2.com

Randomization

Randomization supports block, permuted-block, minimization, multiple schemes, stratification and treatment-kit code management.Read 14 Oct 2026 · servicedesk.launch.openclinica.com

Rating on Apple App Store

4 out of 5 from 4 ratings; the listing is archived and was last seen on 5 October 2025.Read 14 Oct 2026 · appshunter.io

Rating on Capterra

4.6 out of 5 from 37 reviewsRead 14 Oct 2026 · capterra.com

Rating on G2

4.2 out of 5 from 24 reviewsRead 14 Oct 2026 · g2.com

Rating on GetApp

4.6 out of 5 from 37 reviewsRead 14 Oct 2026 · getapp.com

Rating on Software Advice

4.6 out of 5 from 37 reviewsRead 14 Oct 2026 · softwareadvice.com

Recruitment

OpenClinica Recruit provides targeted outreach, prescreening and enrollment analytics and can be used independently or as an add-on.Read 14 Oct 2026 · openclinica.com

Reporting and analytics

OpenClinica offers real-time dashboards, exportable submission-ready data and a Reporting and Analytics module.Read 14 Oct 2026 · openclinica.com

Scale claim

The company says its technology has powered more than 15,000 studies and supported over three million patients.Read 14 Oct 2026 · openclinica.com

Security compliance

OpenClinica states compliance with ICH GCP E6, 21 CFR Part 11, HIPAA and GDPR, and says it is SOC 2 Type II and ISO 27001 certified.Read 14 Oct 2026 · openclinica.com

Self-hosting

Community Edition can be downloaded and hosted on an organization’s own Linux or Windows server, with the user responsible for implementation, validation and support.Read 14 Oct 2026 · openclinica.com

System requirements

Documented single-server minimums are Linux Red Hat or CentOS, quad-core 2GHz CPU, 4GB RAM and 100GB disk; recommended memory is 16GB and disk 500GB.Read 14 Oct 2026 · docs.openclinica.com

Plans and prices

Every OpenClinica plan and price →

Where Specifiction places it

• Life Sciences Software#1 of 288.8
• Research Administration Software#1 of 208.7
• Electronic Data Capture Software#1 of 198.8