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Company description

OpenClinica is an eClinical software platform with over 20 years of experience building technology that puts clinical researchers first. The company serves small to midsize sponsors, contract research organizations (CROs), and academic research teams, offering a complete suite of integrated tools designed to take studies from first patient to database lock with less complexity and more control. With more than 1,500 clients across pharma, biotech, CROs, and academic institutions, OpenClinica has supported over 10,000 studies launched across 100+ countries.

What began as an electronic data capture solution for academic institutions has grown into a full eClinical platform. OpenClinica focuses on teams that value speed, transparency, and meaningful support — whether that is a university researcher launching a first investigator-initiated study or a CRO managing dozens of concurrent trials simultaneously.

eClinical Product Suite

• EDC (Electronic Data Capture): Build studies in hours using drag-and-drop tools, templated CRFs based on CDASH standards, and real-time validation. The interface is designed for ease of use at sites, and the system delivers up to a 50% reduction in data queries.
• eConsent: Multimedia-rich consent experiences featuring comprehension checks, automated notifications, and secure e-signatures. Supports fully remote, in-person, or hybrid consent workflows.
• eCOA (Electronic Clinical Outcome Assessment): Mobile-friendly patient reporting with automated reminders and flexible forms designed to increase compliance and reduce missing data.
• Randomization: Supports simple to complex randomization schemes with blinded or unblinded access, inventory management, and automated notifications — all integrated directly with study data.
• EHR-to-EDC: Pulls lab results, medications, and vitals directly from electronic health records into the EDC, eliminating copy-paste transcription and saving coordinators significant time.
• Reporting & Analytics: Real-time dashboards covering enrollment tracking, query management, and site performance, with customizable reports that give every stakeholder the visibility they need.
• Patient Recruitment: Precision-targeted outreach, smart pre-screening, and real-time analytics designed to achieve predictable enrollment at 3–5x lower cost per conversion compared to traditional recruitment methods.

Platform Capabilities and Approach

• Modular architecture allows organizations to start with only the tools they need and add more as their requirements grow — no forced bundles and no vendor lock-in.
• Drag-and-drop study builder and pre-built CDASH CRF templates enable rapid study setup, often within weeks.
• One-click study publishing streamlines the process from build to launch.
• Real-time edit checks catch errors before they become data quality problems.
• Audit trails and compliance features are built in to support IRB requirements and regulatory submissions.
• Two deployment models are available: self-build for teams that want direct control, and a managed professional services option for lean teams that prefer to focus on science while OpenClinica handles technical setup.

Industries Served

• Academic: University researchers and academic medical centers running investigator-initiated studies, with flexible pricing designed to work within grant budgets.
• Pharma, Biotech, and Medtech: Sponsors ranging from pre-seed startups to established companies, with scalable solutions that grow alongside a pipeline.
• CROs: Contract research organizations managing multiple studies across diverse therapeutic areas, supported by multi-tenant capabilities and centralized oversight.

Customer Support and Partnership Model

• Every client receives a dedicated Customer Success Manager who is familiar with their studies, team, and goals — not a rotating support queue.
• Comprehensive onboarding and partnership support from study design through site training and launch.
• 24/5 application support is available to help sites, coordinators, and data managers whenever questions arise.
• On-demand training through a comprehensive Learning Management System (LMS) for refreshers, new team member onboarding, and feature exploration.
• Professional services are available for teams that need additional hands-on assistance.

Company Philosophy and Notable Details

• OpenClinica operates with a philosophy of transparency — no hidden fees, no surprise upcharges, and no confusing licensing models.
• The product roadmap is driven by customer feedback rather than internal vendor priorities, and the team actively builds features that make sense for researchers.
• Nearly every team member has a background in healthcare or clinical research, meaning support staff understand IRB requirements, audit trails, and query resolution from firsthand experience.
• Long-term customer relationships are a hallmark of the company; clients such as Signifikans have maintained a partnership for over 15 years, using the EDC across pediatric studies, early-phase safety work, and later-phase evaluations.
• The platform has been credited by customers such as RAND Corporation with enabling access to hard-to-reach populations in critical research.

OpenClinica is built for research teams that need clinical trial technology that is powerful enough for regulatory submissions yet straightforward enough that sites genuinely want to use it — backed by a team that treats every client relationship as a long-term partnership.

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Software attributed to OpenClinica

• EDCView
• eConsentView
• eCOAView
• RandomizationView
• UniteView

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