Overview
OpenClinica is a cloud-based eClinical platform built specifically for clinical trial teams who need to move fast without sacrificing compliance or data quality. It brings unified EDC, eConsent, eCOA, randomization, EHR-to-EDC, reporting, and patient recruitment. Smaller teams and beginners may find the initial configuration takes time to get comfortable with, yet the dedicated Customer Success Manager assigned from day one, along with on-demand training, makes it worth every dollar for teams serious about running cleaner, faster trials.
OpenClinica Software Specifications
What is OpenClinica?
OpenClinica LLC provides an eClinical system designed to help research organizations manage clinical trials with greater effectiveness and flexibility.
The system combines electronic data capture, eConsent, eCOA, randomization, analytics, and patient recruitment tools within one centralized environment.
Academic institutions, biotech organizations, government agencies, and pharmaceutical companies use it to manage complex research projects, while accelerating treatment development and improving collaboration.
OpenClinica Integrations
There is no information available about the third-party integrations on the official website, but it does integrate with other platforms.
What is Open Clinica Best for?
OpenClinica Solutions works best for research teams seeking streamlined trial operations, faster study startup, and integrated healthcare research workflows.
The platform supports EHR to EDC connectivity, patient enrollment, and centralized trial management that help reduce data queries and improve study performance.
How To Use OpenClinica EDC?
Add your credentials for a unique OpenClinica login, then navigate to the dashboard. Follow these steps to use this system fully:
- Create a new clinical research study
- Configure study forms and participant workflows
- Add sites, investigators, and research staff
- Set up electronic consent and enrollment steps
- Enter participant data through EDC tools
- Connect EHR data with the study platform
- Randomize participants when required
- Monitor queries and data validation checks
- Track recruitment and enrollment progress
- Review analytics and study performance reports
Schedule a free OpenClinica demo for more details and to learn about the OpenClinica community edition.
Who Is Open Clinica Software For?
This system can be leveraged by:
- Academic research institutions
- University medical centers
- Pharmaceutical companies
- Biotechnology companies
- Medical device companies
- Contract research organizations (CROs)
- Government research agencies
- Life sciences organizations
- Hospital research departments
- Nonprofit research institutions
How Much Does OpenClinica Cost?
It offers four plan tiers designed to match different team sizes and study complexity levels. Professional services are available as add-ons at hourly rates.
- Launch: $750/month (no annual contract)
- Core: $3,000/month/study (12-month contract)
- Advanced: $3,750/month per study (12-month contract)
- Enterprise and Academic: Custom OpenClinica pricing
Professional Services (Add-on)
- Consulting: $275/hr
- Training: $300/hr
- Engineering: $350/hr
- Volume packages: Custom pricing for 25, 50, or 100+ hour bundles
Connect with us for a tailored quote.
Why Choose Open Clinica?
Your clinical organization benefits from a highly scalable cloud architecture that easily supports everything from a single-site study to complex, multi-national trials. It maintains strict compliance with FDA 21 CFR Part 11 and GDPR requirements, holding official SOC 2 Type II certification to ensure your clinical records stay safe and encrypted.
Contact our client support team if you have any doubts. You can also watch a free demo and read unbiased OpenClinica reviews.
OpenClinica Features
OpenClinica EDC lets teams build studies using drag-and-drop tools or pre-loaded CDASH templates and publish them in hours. Real-time edit checks catch data errors the moment they happen, reducing data queries by up to 50%.
The eCOA module gives patients a mobile-friendly way to report outcomes directly without clinic visits. Automated reminders go out to keep compliance rates up, and the forms are designed to be clear and approachable so patients actually complete them. The data feeds directly into the study database without manual re-entry, reducing the chance of transcription errors.
OpenClinica login handles participant consent through a fully digital workflow that supports remote, in-person, or mixed delivery. Consent forms can include multimedia elements and comprehension checks. Electronic signatures are captured securely, and automated notifications go out when reconsent is needed.
The reporting and analytics module gives every stakeholder a real-time view of where the study stands, from enrollment numbers to query counts to site performance. Dashboards are customizable, so each team sees the data that matters to their role, and reports can be exported when deeper analysis is needed outside the platform.
OpenClinica Recruit targets the right patient populations using precision outreach tools, smart pre-screening, and real-time analytics to keep enrollment on track. Pre-screening logic is built around the study’s own eligibility criteria, so site coordinators spend less time reviewing ineligible candidates.
See The Software In Action Watch Free Demo!
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OpenClinica Pros and Cons
OpenClinica Reviews
My software review
Pros
The platform has been a dependable part of our daily operations. It handles core tasks smoothly and keeps everything organized without adding complexity.
Cons
Limited advanced customization options.
An excellent System
Pros
The software offers a good mix of features that support our workflow and improve efficiency. It covers most of our needs, though there are occasional areas where improvements could enhance usability. Still, it delivers solid value for the price.
Cons
Occasional lag in updates or syncing.
Frequently Asked Questions (FAQs)
Certainly not, Open Clinica does not have a free plan available.
Yes, OpenClinica software is cloud-based.
English is the language that the OpenClinica platform supports.
OpenClinica allows users to get answers through phone support, a knowledge base, ticketing support, and email. It also offers a dedicated Customer Success Manager. You can also get details about OpenClinica pricing.
OpenClinic software is accessible through a web-based platform that supports remote access for study teams and site coordinators. Users can access platform functionality through a single OpenClinica login.
Yes, the OpenClinica API is available, supporting both REST and SOAP methods.
Yes, the OpenClinica system supports access via mobile devices, particularly for patient-facing eCOA and eConsent workflows, with an OpenClinica login required to access the platform.
OpenClinical does not publicly list a free trial, but you can request a demo or reach out to the sales team to discuss options before committing to a plan.
