Tool profile
OpenClinica: cost, fit and limits
OpenClinica is an eClinical platform made by OpenClinica, LLC of Needham, Massachusetts, that offers EDC, eConsent, eCOA, randomization, EHR-to-EDC and reporting. Small and mid-size sponsors, CROs and academic teams use it, and the company will build studies for clients, including validation documentation.
What to know first
OpenClinica is one of the few vendors in this category that prints study pricing: Launch at $750 a month, Core at $3,000 and Advanced at $3,750, each with stated limits or contract terms. Professional services have hourly rates. The pages we read describe no AI features, so it works as a priced reference point next to AI-led rivals. Hosting providers sit in the United States, the EU and other locales, and no single region is promised.
OpenClinica at a glance
| Maker | OpenClinica, LLC, United States |
|---|---|
| Free plan | Free trial only |
| Entry price | $750 per month for Launch |
| API access | Yes |
| Category | Best AI Clinical Trial Software in 2026, rank 6 of 11 |
| Website | openclinica.com |
Who OpenClinica is best for
Academic teams on grant budgets
The pricing page offers flexible pricing for academic customers and a free study build with EDC engagements, which helps when a grant fixes the budget.
First-time sponsors
Launch at $750 a month with no annual contract, 150 participants and 3 sites gives a small study a cost it can plan with, plus a 30-day trial.
Teams that outsource the build
OpenClinica states it can build studies for free using CDASH templates, including validation documentation, which suits groups without a data manager.
OpenClinica plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Launch | $750 per month | EDC only, billed monthly with no annual contract. Includes 150 participants, 3 sites and a 30-day free trial. |
| Core | $3,000 per month per study | 12-month contract with EDC, reporting and analytics, API access, a dedicated customer success manager and a fully isolated EDC. |
| Advanced | $3,750 per month per study | Core plus one add-on module (eCOA, eConsent or Randomization), MFA and SSO, and 10 hours of professional services. |
| Enterprise and Academic | Custom annual pricing | For 20 or more studies with all modules unlocked. Services are $275 per hour for consulting, $300 for training and $350 for engineering. |
Checked November 2026.
What OpenClinica does
- EHR-to-EDC
- The platform pulls lab results, medications and vitals from electronic health records into the EDC, which removes some manual transcription at sites. Sites then check the imported values instead of retyping them.
- Pre-built study templates
- Teams can build studies themselves from CDASH templates with drag-and-drop tools, or ask OpenClinica to build them, which the company says it does for free.
- eConsent and eCOA
- eConsent includes multimedia content, comprehension checks and e-signatures, and eCOA lets participants report outcomes on a mobile device. Participants can answer outcome questionnaires on their phones, which supports remote and hybrid study designs.
- Randomization
- Blinded or unblinded randomization with inventory management is a module, available as the add-on in the Advanced tier. Inventory management for study supplies is described alongside the allocation logic.
- Customer support model
- Every client gets a customer success manager, 24/5 application support and on-demand training through a learning system. Support covers application questions on weekdays and training content on demand.
How OpenClinica handles your data
OpenClinica's privacy policy names OpenClinica, LLC at 163 Highland Avenue in Needham, Massachusetts, and says it uses data hosting providers in the United States, the European Union and other locales. When a customer leaves, clinical data is deleted and backups are overwritten in the ordinary course of reuse. The policy does not address AI training and names no subprocessors. The pricing page lists 21 CFR Part 11, HIPAA, GDPR, SOC 2 and ISO 27001, and Core includes a fully isolated EDC without a stated hosting region.
Where OpenClinica falls short in practice
- No AI on the pages read. The product and pricing pages describe no AI. Teams that want protocol-to-study building or automatic extraction must pick another vendor. Ask the vendor for a roadmap in writing.
- Per-study pricing adds up. Core and Advanced are priced per study per month, so a sponsor with several parallel studies should price the Enterprise tier early. Model the full contract term and the number of studies before choosing between Core and Enterprise.
- Hosting region is vague. The privacy policy lists the US, the EU and other locales without tying a customer to one, so confirm the region in the order form.
Works with
Alternatives to OpenClinica
OpenClinica: common questions
What does OpenClinica cost per month?
Launch is $750 per month billed monthly with no annual contract. Core is $3,000 per month per study on a 12-month contract, and Advanced is $3,750. Enterprise and Academic pricing is custom for 20 or more studies. Professional services are billed hourly.
Does OpenClinica have a free trial?
Launch includes a 30-day free trial, and the pricing page also mentions a free expert-managed study build with EDC engagements. It lists no permanent free tier, and the trial is for the EDC-only Launch plan. Ask what the trial includes before you load any real participant data.
Does OpenClinica use AI?
The pricing page does not mention AI features, and the pages we read describe EHR-to-EDC, eConsent, eCOA and randomization without AI. If AI extraction or study building is a requirement, ask the vendor for a written product roadmap. Ask the vendor whether any machine learning runs on study data.
What happens to my data when I leave OpenClinica?
The privacy policy says clinical data is deleted when a customer stops being a customer, and backups are overwritten in the ordinary course of reuse. Export your data, queries and audit trail before cancellation. Ask about the timing of deletion in writing.
Which compliance standards does OpenClinica list?
The pricing page lists 21 CFR Part 11, HIPAA, GDPR, SOC 2 and ISO 27001. These are vendor statements on a marketing page, so ask for the SOC 2 report and the ISO certificate. Core also includes a dedicated, fully isolated EDC according to the pricing page.