OpenClinica
Electronic data capture (EDC) software
Life sciences software
Clinical research software
- Features
- Ease of use
- Ease of management
- Quality of support
- Affordability
- Market presence
Take the quiz to check if OpenClinica and its alternatives fit your requirements.
Contact the product provider
Free Trial unavailable
Free version
Small
Medium
Large
- Healthcare and life sciences
- Public sector and nonprofit organizations
- Agriculture, fishing, and forestry
What is OpenClinica
OpenClinica is an electronic data capture (EDC) platform used to design and run clinical studies by collecting, validating, and managing clinical trial data. It supports study build activities such as eCRF design, edit checks, role-based access, and audit trails for regulated research. Typical users include clinical operations teams, data managers, and research sites running sponsor-led or investigator-initiated studies. The product is commonly deployed as a cloud service and is also known for having an open source lineage alongside commercial offerings.
Flexible study build options
The platform supports configurable study design, including form creation and validation rules to enforce data quality at entry. Teams can adapt study workflows to different trial designs and operational models without requiring a fully custom-built system. This flexibility is useful for organizations running multiple protocols with varying complexity.
Strong core EDC capabilities
OpenClinica provides the core functions expected in an EDC: eCRF/eCRF library management, query workflows, role-based permissions, and audit trails. It supports multi-site study execution with controlled access for monitors, data managers, and site staff. These capabilities align with standard requirements for regulated clinical research data collection and review.
Open source heritage and ecosystem
OpenClinica has an established history in the clinical research community, including an open source edition that influenced adoption and integrations. This background can reduce vendor lock-in concerns for some organizations and supports a broader ecosystem of implementers and experienced users. It can be a fit for teams that value transparency and extensibility alongside a commercial support model.
Implementation effort can be material
Study build, validation, and user provisioning typically require specialized EDC configuration skills and disciplined governance. Organizations without experienced data management resources may need services support to meet timelines. This can increase total effort compared with more prescriptive, out-of-the-box setups.
Advanced eClinical breadth varies
Organizations seeking a single, tightly integrated suite across EDC plus adjacent eClinical functions (for example, broader clinical operations or end-to-end platform capabilities) may need additional systems or integrations. The degree of native coverage depends on the specific OpenClinica edition and modules in use. This can add integration and vendor-management overhead.
UI and workflow preferences differ
User experience, monitoring workflows, and reporting expectations vary widely across sponsors and CROs, and some teams may prefer alternative interaction patterns found in other EDCs. Training and change management may be required for sites and monitors when standard workflows differ from prior systems. Fit should be validated through a pilot using representative study scenarios.
Plan & Pricing
| Plan | Price | Key features & notes |
|---|---|---|
| Community (Open source) | Free (self-hosted) | Unlimited users/sites/forms; self-hosted, not validated, no dedicated vendor support; download via OpenClinica Community portal. |
| Enterprise (OC3 / OC4 SaaS) | Custom pricing — contact sales | Validated, cloud-hosted SaaS with compliance support, dedicated vendor support, integrations and optional modules (ePRO, IxRS, reporting). Site notes a low setup fee plus monthly subscription; contact sales for quote. |
| Recruit (participant recruitment service) | Custom pricing — contact sales; on average $1,000–$3,000 per month for studies | Digital participant recruitment service; pricing is tailored to study criteria (inclusion/exclusion, targets, timeline). OpenClinica states average study costs in the $1,000–$3,000/month range. |
Seller details
OpenClinica, LLC
Waltham, Massachusetts, USA
2003
Private
https://www.openclinica.com/
https://x.com/openclinica
https://www.linkedin.com/company/openclinica/
