OpenClinica

Clinical trial EDC with a genuinely open source community edition alongside a quoted commercial platform

As of 31 August 2026, OpenClinica's pricing is not published; the vendor quotes on request. Electronic data capture for clinical trials, split between a free LGPL community edition that you host and support yourself and a commercial eClinical platform sold by quote. Softwr lists it under Healthcare. OpenClinica is made by OpenClinica, LLC, available on Web, Self-hosted, iOS, Android.

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Overview

What OpenClinica does

OpenClinica is electronic data capture and clinical data management software for interventional and observational studies. The commercial platform unites EDC, eConsent, eCOA and electronic patient reported outcomes, randomisation, EHR-to-EDC data import, reporting and analytics, and patient recruitment, all delivered as a validated hosted service. It is used across academic medical centres, contract research organisations, medical device companies and investigator-initiated trials. The fact worth knowing before shortlisting is that the free community edition and the commercial product are not the same software on different support terms. The community edition sits on the older 3.x line, released under the LGPL and available on GitHub, with releases still appearing through 2025, while the commercial offering is built on the newer generation with the modern form builder, eConsent, eCOA and analytics that the community build does not contain. The vendor states plainly that it offers no support or services for the free edition. So the open source route means you host it, you patch it, you write your own validation package, and you accept a feature set from a previous architecture. That is entirely viable for an academic group with informatics staff and no sponsor breathing down its neck, and unworkable for a regulated submission where the validation documentation and audit trail assurance are the thing you are buying. Commercial pricing is not published and comes only through a quote, with third-party listings suggesting enterprise arrangements starting in the region of USD 1,000 per month, though real cost depends on study count, subject numbers, module mix and whether you need the vendor to build the forms. Buyers are typically academic coordinating centres and small to mid-size sponsors that want 21 CFR Part 11 compliant capture without the price of the large enterprise eClinical suites.

What people use it for

An academic coordinating centre running investigator-initiated trials that needs Part 11 compliant capture without an enterprise eClinical budget
A registry or observational cohort study collecting structured data across many sites over years
A small device sponsor that needs eConsent and ePRO in the same system as its case report forms
An informatics group that wants to self-host the open source edition for a non-regulated internal study

Where it falls short

Concrete and checkable, so you can decide whether any of them matter to you. This is the half of a review a vendor will not write about OpenClinica.

The free community edition is a different and older product line from the commercial platform, so evaluating the open source build tells you little about what the paid product actually does.
The vendor provides no support or services at all for the community edition, which means outages, patching, database upgrades and validation documentation are entirely your problem.
Commercial pricing is not published, so you cannot benchmark it against alternatives without entering a sales process, and third-party figures around USD 1,000 a month are indicative rather than contractual.
Study build is skilled work: complex edit checks, randomisation schemes and integrations usually mean paying for vendor or consultant configuration services on top of the licence, which is a frequently underestimated line in the budget.
As a smaller vendor than the large eClinical suites it has a thinner partner and consultant ecosystem, so finding experienced build staff or a CRO already fluent in the platform is harder than with the market incumbents.

Pricing

What OpenClinica costs

Taken from the vendor's own pricing page. Prices move, so check before you buy.

Community Edition

On request

Free and open source under the LGPL
Self-hosted, on the older 3.x line
No vendor support or services of any kind
You produce your own validation documentation
Does not include eConsent, eCOA or the modern form builder

OpenClinica Enterprise

On request

Pricing only through a sales process
Hosted and validated instance
EDC, eConsent, eCOA, randomisation and analytics modules
21 CFR Part 11 and GCP aligned audit trail
Study build services quoted separately from the licence

Capabilities

Features

Open source community edition
LGPL 3.x release on GitHub, self-hosted and unsupported
Electronic data capture
Study build, form design, edit checks and data queries
eConsent
Electronic informed consent within the same platform
eCOA and ePRO
Patient reported outcome collection on participant devices
Randomisation
Subject randomisation integrated with data capture
EHR-to-EDC
Import of source data from electronic health records to reduce transcription
Audit trail
21 CFR Part 11 aligned electronic records and signatures in the commercial edition
Reporting and analytics
Study monitoring, data review and extract generation

Answered, with sources

Questions people ask

Each answer names the page it came from, so you can check it rather than take our word for it.

Is OpenClinica free?

There is a genuinely free, LGPL licensed community edition you host yourself with no vendor support. The commercial platform with eConsent, eCOA and a validated hosted instance is quoted and paid.

Is the open source version still maintained?

Yes, releases on the 3.x line continued through 2025, but it is a separate and older architecture from the commercial product.

Does it meet 21 CFR Part 11?

The commercial hosted platform is built for Part 11 and GCP compliance. If you self-host the community edition, compliance and validation are entirely your responsibility.

What does the commercial version cost?

Not published. Third-party listings suggest enterprise arrangements from around USD 1,000 per month, but real cost depends on study count, subjects, modules and build services.

Keep looking

Where to go from OpenClinica

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Softwr does not host reviews and shows no star rating for OpenClinica, because a rating we did not collect is not ours to publish. What is here is the pricing and platform detail from the vendor’s own pages, limitations we could state concretely, and alternatives a reviewer confirmed people weigh against it. Tell us if any of it is wrong.

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