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OpenClinica Review

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Should I use OpenClinica?

Introducing Study Hub — Recruitment, engagement, and clinical data capture in one connected platform. - openclinica.com

· 17 hours ago

Buy if you run regulated clinical trials and need a validated, compliance-heavy EDC (ISO 27001, SOC 2, FedRAMP program). Skip it for simple registries, small unregulated studies, or if you want transparent self-serve pricing — REDCap or a lighter EDC fits better.

Confidence

Medium. Based on ~30 public sources; review snippets were truncated and no named customers surfaced.

Ratings

  • Value for money
  • Ease of use
  • Feature depth
  • Support qualityNo directional evidence found in sources
  • Security posture

Pricing

Free

Community Edition

ModelNot disclosed
Monthly feesNot disclosed
HardwareNot disclosed
Free tierYes
Enterprise / CloudQuote-based

Best for

  • Sponsors and CROs running regulated trials
  • Multi-centre academic studies
  • Government-adjacent research needing FedRAMP
  • Teams consolidating recruitment and EDC

Not for

  • Small labs needing a quick simple database
  • Non-clinical surveys or registries
  • Teams without capacity for study build and validation
  • Buyers wanting self-serve transparent pricing

Gotchas - check before you buy

high

Self-hosted Community Edition means you own patching, upgrades, and regulatory validation.

medium

Guess: enterprise pricing is quote-based and likely per-study; budget before the demo.

medium

Two 2025 CVEs disclosed; patch self-hosted installs promptly and track versions.

medium

Guess: extracting data and audit trails when switching EDCs is slow and costly.

Pros and cons

Pros

  • Recruitment, engagement, and clinical data capture combined in one platform
  • ISO 27001 certified and SOC 2 audited for security controls
  • FedRAMP program targeted at government clinical research
  • Free, self-hostable open-source Community Edition
  • Multifactor authentication and granular user access controls built in

Cons

  • Middling 3.6/5 aggregate rating across 61 reviews
  • Guess: no transparent pricing; enterprise deals require sales quotes
  • Two 2025 CVEs disclosed, including a CVSS 8.8 path traversal
  • Community Edition requires self-hosting plus your own validation burden

Sources & method

- 10 sources - ISO 27001 certified, SOC 2 audited, MFA available — but two 2025 CVEs (XXE and a CVSS 8.8 path traversal) were disclosed.

official x2review x4security x3news x1
  • CVE-2025-12921 — XXE vulnerability in OpenClinica, XML External Entity vulnerability disclosed against OpenClinica; apply vendor patches.
  • CVE-2025-12922 — Path traversal (CVSS 8.8), High-severity path traversal vulnerability in OpenClinica rated 8.8.
  • CVE-2022-24830, Older NVD entry (May 2022) referencing OpenClinica; verify applicability to your version.

Key stats

  • Value for money: 3/5

    Rating

  • Free

    Starting price

  • 10

    Sources

  • Analyzed

  • Value for money: 3/5. Free community edition; enterprise is quote-based
  • Ease of use: 3/5. 3.6/5 aggregate suggests mixed user experience
  • Feature depth: 4/5. Recruitment, engagement, EDC, MFA, FedRAMP
  • Support quality. No directional evidence found in sources
  • Security posture: 3/5. ISO 27001 and SOC 2, but 2025 CVEs
  • 3.6/5 Aggregate rating 61 reviews
  • Yes Free tier Open-source Community Edition
  • PE-backed Backing Thompson Street Capital growth investment, 2023
  • ISO 27001 Security certs SOC 2 audited; FedRAMP program

Pricing

Community Edition

Free

  • Open-source EDC
  • Self-hosted

Enterprise / Cloud

Quote-based

  • Hosted, validated environment
  • Study Hub recruitment and engagement modules
  • Compliance support documentation

Security

ISO 27001 certified, SOC 2 audited, MFA available — but two 2025 CVEs (XXE and a CVSS 8.8 path traversal) were disclosed.

  • CVE-2025-12921 — XXE vulnerability in OpenClinicaXML External Entity vulnerability disclosed against OpenClinica; apply vendor patches.⁸
  • CVE-2025-12922 — Path traversal (CVSS 8.8)High-severity path traversal vulnerability in OpenClinica rated 8.8.⁷
  • CVE-2022-24830Older NVD entry (May 2022) referencing OpenClinica; verify applicability to your version.

What users say

Reviews are middling — a 3.6/5 aggregate over 61 reviews — with buyers most often comparing it head-to-head against Castor, Medrio, and Medidata.

Alternatives

Compare OpenClinica with each alternative.

  • REDCap

    Free or cheap academic EDC; the default for simple studies.

  • Castor EDC

    Modern rival, frequently compared head-to-head on usability.

  • Medrio EDC

    Lightweight EDC aimed at faster study builds.

Full analysis

Based on ~30 public sources; review snippets were truncated and no named customers surfaced.

Validated clinical-trial EDC with strong compliance credentials; overkill and quote-priced for small, unregulated studies.

Methodology

Based on ~30 public sources; review snippets were truncated and no named customers surfaced.

Read how a report is made.

Sources

  1. OpenClinica Reviews on G2g2.com
    review
  2. OpenClinica vs Castor (RFP.wiki)rfp.wiki
    review
  3. OpenClinica Reviews on GetAppgetapp.ie
    review
  4. Reddit r/HealthInformatics database recommendationsreddit.com
    review
  5. OpenClinica Trust and Complianceopenclinica.com
    official
  6. OpenClinica FedRAMP for Clinical Researchopenclinica.com
    official
  7. CVE-2025-12922 Detail (NVD)nvd.nist.gov
    security
  8. CVE-2025-12921 OpenClinica XXE (SentinelOne)sentinelone.com
    security
  9. CVE-2025-12922 Path Traversal (Strix)strix.ai
    security
  10. Thompson Street Capital growth investment in OpenClinicatscp.com
    news

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