EDC platform review

OpenClinica review

OpenClinica is an electronic data capture platform offered as a cloud-hosted Enterprise subscription with optional eCOA, eConsent and randomisation modules, and as a free open-source Community Edition. It is used by sponsors, CROs, academic institutions and non-profits running clinical studies.

Facts checked: November 2026 · Rank 2 of 18 · How we rank

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Our score: 7.7/10
Best for: Small to mid studies wanting published prices or open-source software
Pricing: Per-study monthly subscription with add-on modules; free open-source Community Edition
Vendor: OpenClinica, LLC, Waltham, Massachusetts, USA

Unique feature

Open-source Community Edition

Alongside its cloud product, OpenClinica offers a free Community Edition under the LGPL licence; the vendor states it is not validated, has no dedicated support and must be hosted on your own server.

Fit

Who OpenClinica suits

Best for

Small studies wanting a published monthly price (Launch plan: up to 150 participants, 3 sites)
Sponsors or CROs running several concurrent studies
Institutions with IT staff able to self-host the open-source edition

Less suited to

Regulated trials on the Community Edition, which the vendor lists as not validated
Teams without IT resource wanting a free option, as Community must be self-hosted
Studies needing randomisation on the entry Launch plan, where it is not a listed add-on

Features

Key features

What the vendor documents publicly, checked against its own pages. “Not stated” means we could not confirm it, not that it is missing.

✓ Yes◐ Partly+ Add-on– No? Not stated

✓Vendor builds your databaseExpert-managed study build included in Core, Advanced and Enterprise plans
✓Build forms yourselfDrag-and-drop study designer (OC4 Enterprise); basic forms in Community
✓Audit trailAudit trail listed; Reason for Change in all editions
✓Electronic signaturesInvestigators apply electronic signatures to participant records
✓Edit checks at data entryReal-time and cross-form edit checks in OC4
✓Queries and source data verificationQueries fire on unresolved edit checks; SDV data in reporting
+RandomisationEnterprise module with blinding and stratification; not in Community
+ePRO and participant self-entryeCOA module for diaries and surveys on any device
+eConsenteConsent module, sold separately or in Advanced/Enterprise plans
✓Offline mobile data collectionVendor lists offline capture for Enterprise ePRO/eCOA
✓Forms in several languagesForm translations; languages enabled by Customer Support
✓CDISC export (ODM / SDTM)CDISC ODM dataset export and ODM XML API
✓Built-in reports and dashboardsInteractive visual reports and custom dashboards (Enterprise)
?Built-in statistical analysisExports to SPSS and SAS formats
?Numbered tables, figures and listings
✓APIBasic API in Community/OC3, enhanced in OC4
✓Free or open-source optionOpen-source Community Edition (LGPL), self-hosted; 30-day trial on Launch

Verdict

Strengths and limitations

Strengths

Published monthly prices for Launch, Core and Advanced plans
Free open-source Community Edition for self-hosting
CDISC ODM-based exports and API

Limitations

Community Edition is not validated and has no dedicated support
ePRO, eConsent and randomisation are paid add-on modules
Launch plan limited to 150 participants and 3 sites

Details

Pricing, hosting and regulation

Pricing

Per-study monthly subscription with add-on modules; free open-source Community Edition. Published prices: Launch (EDC only) $750/month, no annual contract, up to 150 participants and 3 sites; Core $3,000/month per study (12-month contract); Advanced $3,750/month per study (12-month contract, one add-on module); Enterprise & Academic custom. Services $275-$350/hour.. Pricing source.

Hosting and security

Hosting regions: US, UK and EU (Enterprise cloud). Enterprise is vendor cloud-hosted; Community Edition must be hosted on your own server.

Certifications: SOC 2 examination report, 2023 (vendor; Type not stated).

Regulatory support

Vendor states Enterprise is "Compliant with 21 CFR Part 11, ICH GCP, Annex 11, HIPAA, GDPR"; Community "Not validated".. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.

Scale and set-up

Vendor states it has powered over 15,000 studies and supported more than three million patients, with studies from 20 to 200,000 patients.. Vendor claims studies can launch "in 2-3 weeks instead of 3-6 months". Self-build in the study designer or expert-managed build included in higher plans..

Alternatives

Sources (checked November 2026)