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OpenClinica

by OpenClinica · Since 2004
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ActiveAvailable globallyCloudOn-premise
Quick facts
VendorOpenClinica
Year launched2004
StatusActive
Location163 Highland Avenue #1173 Needham, MA 02494 USA
Countries servedGlobal
Languages12
IntegrationsN/A
Free tierN/A
Free trialN/A
Contact salesYES

About OpenClinica

OpenClinica is a clinical trial management software from OpenClinica that supports data collection and management for clinical research. It provides features such as electronic data capture, study management, and reporting tools so researchers can efficiently manage clinical trials. OpenClinica facilitates compliance with regulatory standards and ensures accurate data collection through its reliable platform. The software is designed for both experienced and novice users in the clinical research field. Key capabilities: electronic data capture study management data reporting regulatory compliance user-friendly interface Best for: clinical researchers and organizations that need an effective solution for managing clinical trials and ensuring data integrity.

OpenClinica by OpenClinica is a leading electronic data capture (EDC) software designed to support the rigorous data management needs of life science companies, academic institutions, and government entities. Its primary purpose is to streamline the process of clinical data collection and management, enabling organizations to conduct clinical trials with enhanced accuracy, compliance, and efficiency. The platform offers a comprehensive suite of features, including electronic case report form (eCRF) creation, data validation, audit trails, and real-time data monitoring, making it an essential tool for organizations engaged in clinical research. The user interface of OpenClinica is thoughtfully designed to facilitate ease of use and rapid adoption by both novice and experienced users. The dashboard provides a clear, at-a-glance view of key metrics such as study progress, data quality, and pending tasks. Navigation is intuitive, with clearly labeled menus and streamlined workflows that guide users through study setup, data entry, and analysis. A unique aspect of the interface is its modular design, which allows users to customize the layout to suit their specific workflow requirements.

Pros & Cons

Pros
  • Easy to use: OpenClinica is praised for its user-friendly interface, making it simple to create and manage data collection forms.
  • Customizable: The software offers a high degree of customization, allowing users to tailor the system to their specific needs.
  • Comprehensive features: OpenClinica provides a wide range of features, including EDC, ePRO/eCOA, RTSM, and reporting, covering various aspects of clinical trial management.
  • Good customer support: Users appreciate the responsive and helpful customer support provided by OpenClinica.
Cons
  • Limited automatic scheduling: While this is reportedly being improved, the current automatic scheduling functionality has some limitations.
  • Browser compatibility: Some users have reported issues with using OpenClinica on certain internet browsers.
  • Limited built-in edit checks: The built-in data validation and edit checks could be more robust.

Features

Key features

Electronic Data Capture (EDC) & Clinical Data Management

Streamlined study design, smart forms, automated calendaring, and data automation.

EHR to EDC eSource Integration

Reduces site burden, saves time and cost, enables early data-driven decisions, and supports diverse study types.

Reporting Dashboards & Data Analysis

Real-time information, customizable reports and dashboards, and documented data tables.

Patient Reported Outcomes (ePRO) and Electronic Clinical Outcome Assessments (eCOA)

Patient-centric approach, automated notifications, compliance and validation, and multimedia/multilingual support.

Randomization & Supply Chain

Integrated workflow, flexible randomization options, complete sample tracking, and clear reporting.

eConsent

Improved efficiency, enhanced patient access and engagement, multimedia experience, and automated workflows.

Patient Engagement (OpenClinica Recruit)

Facilitates patient recruitment for clinical research.

Additional features

Self-service study building

Design and launch studies without needing IT expertise.

Smart forms (eCRFs)

Create dynamic electronic case report forms with real-time edit checks, skip logic, and auto-save to ensure data quality and efficiency.

Drag-and-drop interface

Simplify the design of even complex studies with an intuitive visual interface.

Automated study calendaring

Streamline scheduling of visits, protocol events, and notifications.

Data automation

Orchestrate complex data pipelines and workflows with ease.

EHR to EDC eSource Integration
Seamless data transfer

Integrate Electronic Health Records (EHR) with the EDC system for automated data capture.

Reduced site and clinician burden

Minimize manual data entry and transcription.

Time and cost savings

Reduce the need for Source Data Verification (SDV).

Early data-driven decisions

Access real-time results for faster insights.

Support for diverse study types

Applicable to clinical trials, Real-World Evidence (RWE) studies, and digital health initiatives.

Reporting Dashboards & Data Analysis
Out-of-the-box report library

Access pre-built reports for common analyses.

Custom reports & dashboards

Create tailored visualizations using a point-and-click builder.

Documented tables & fields

Easily understand and browse data with clear documentation.

Configurable roles

Manage access and permissions for different users.

Patient Reported Outcomes (ePRO) and Electronic Clinical Outcome Assessments (eCOA)
Patient-centric approach

Enhance patient engagement and compliance.

Automated notifications

Remind patients and study teams about tasks and appointments.

Compliance & validation

Utilize validated instruments and Informed Consent Forms (ICFs).

Multi-media & multilingual

Support diverse patient populations with accessible content.

Randomization & Supply Chain
Integrated workflow

Manage randomization within the eCRF system.

Comprehensive & flexible

Support various types of randomized clinical trials.

Complete sample tracking

Monitor samples digitally throughout the study lifecycle.

Clear reporting

Provide insights to sites, Principal Investigators (PIs), and study teams.

eConsent
Improved efficiency

Streamline the consent process.

Enhanced patient access & engagement

Make consent materials easily accessible and understandable.

Multimedia experience

Incorporate videos, animations, and other media.

Automated workflows

Support patients and clinicians with automated steps.

Patient Engagement (OpenClinica Recruit)
Targeted recruitment

Efficiently identify and recruit eligible patients for clinical trials.

Streamlined process

Simplify patient recruitment workflows.

Improved enrollment rates

Accelerate trial timelines.

Additional Features/Capabilities
Cloud-based platform

Access the system from anywhere with an internet connection.

Secure data management

Ensure data privacy and compliance.

Support for various research organizations

Cater to the needs of biotech, pharma, academia, medical device, and CROs.

Resources section

Access news, papers, and publications.

Demo request form

Schedule a personalized demonstration.

Integrations

Expand capabilities through partnerships and acquisitions (e.g., BuildClinical).

Pricing

Free trial
Free version
Request a quote
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Countries & Languages

Global
Countries served
12
Interface languages
15
Billing currencies

Interface languages

EnglishSpanishFrenchGermanPortugueseItalianDutchRussianChineseJapaneseKoreanArabic

Billing currencies

🇺🇸USD🇪🇺EUR🇬🇧GBP🇯🇵JPY🇦🇺AUD🇨🇦CAD🇨🇭CHF🇨🇳CNY🇸🇪SEK🇮🇳INR🇸🇬SGD🇭🇰HKD🇲🇽MXN🇳🇿NZD🇰🇷KRW

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