OpenClinica

OpenClinica

OpenClinica  ❘ Open Source
iOS
Latest Version
 
Safe to install

Transform Your Clinical Trials with OpenClinica

Elena Angelini

OpenClinica offers an intuitive and robust platform for managing clinical data, making it a powerful tool for researchers and institutions looking to streamline their trial processes.
2025 Editor's Rating

OpenClinica: A Comprehensive Overview

OpenClinica is a powerful and user-friendly open-source software application designed for the collection and management of clinical research data. It provides researchers, scientists, and healthcare professionals with a robust platform to streamline data capture, monitoring, and analysis processes in clinical trials and research studies.

Key Features:

  • Electronic Data Capture (EDC): OpenClinica offers an intuitive interface for efficient and accurate electronic data capture, allowing users to collect data securely in compliance with regulatory standards.
  • Study Design and Management: Users can design, customize, and manage their research studies with ease, including creating forms, defining study events, and setting up study workflows.
  • Data Monitoring: The software enables real-time data monitoring and discrepancy management to ensure data quality and integrity throughout the study lifecycle.
  • Reporting and Analysis: OpenClinica provides powerful reporting tools for generating custom reports and visualizing study data for in-depth analysis and decision-making.
  • Integration and Interoperability: The application supports seamless integration with other systems and tools to facilitate data exchange and interoperability in multi-center studies.
  • Regulatory Compliance: OpenClinica adheres to global regulatory standards such as FDA 21 CFR Part 11, ensuring data security, audit trails, and electronic signatures for compliance purposes.

Benefits:

  • Efficient Data Collection: Streamline data capture processes with user-friendly forms and validation rules.
  • Data Quality Assurance: Real-time monitoring and discrepancy management enhance data quality and accuracy.
  • Cost-Effective Solution: Being open-source, OpenClinica provides a cost-effective alternative for organizations with budget constraints.
  • Customizable Platform: Tailor the software to meet the specific requirements of different research studies and clinical trials.

OpenClinica is a comprehensive and reliable solution for managing clinical research data effectively. With its robust features, regulatory compliance, and ease of use, it is a valuable tool for researchers seeking to streamline their data collection and analysis processes in clinical trials and research studies.

Overview

OpenClinica is a Open Source software in the category Development developed by OpenClinica.

The latest version of OpenClinica is currently unknown. It was initially added to our database on 11/03/2011.

OpenClinica runs on the following operating systems: iOS.

OpenClinica has not been rated by our users yet.

Pros

  • OpenClinica is an open-source, web-based electronic data capture (EDC) and clinical data management system, which means it is freely available to use without license fees.
  • It is highly customizable, allowing users to adapt the system to their specific study needs and workflows.
  • OpenClinica offers comprehensive support for regulatory compliance, including 21 CFR Part 11, HIPAA, and GCP.
  • It has a user-friendly interface that simplifies data entry and management tasks, making it easier for researchers to navigate and use the software efficiently.
  • The system provides robust reporting capabilities, allowing users to generate customized reports and track study progress effectively.
  • OpenClinica offers multi-language support, making it accessible to a wider user base across different regions.

Cons

  • Despite being open-source, users may still incur costs related to hosting, maintenance, and support services.
  • The system may require some technical expertise to fully leverage its customization features, which could pose a challenge for less experienced users.
  • Integration with other systems or data sources may require additional development work, potentially adding complexity to the implementation process.
  • As an open-source solution, the community support for troubleshooting and updates may vary in responsiveness compared to commercial software providers.
  • The user community for OpenClinica may be smaller than that of some commercial EDC systems, limiting access to resources such as templates or plugins created by other users.

FAQ

What is OpenClinica?

OpenClinica is a web-based electronic data capture (EDC) system for clinical research studies.

How is OpenClinica used in clinical trials?

OpenClinica is used to collect, manage, and report data for clinical trials, ensuring data quality and compliance with regulatory requirements.

Is OpenClinica compliant with regulatory guidelines?

Yes, OpenClinica is compliant with regulations such as 21 CFR Part 11 and GCP (Good Clinical Practice) guidelines.

Can OpenClinica be integrated with other systems?

Yes, OpenClinica can be integrated with other systems such as EHRs (Electronic Health Records) and CTMS (Clinical Trial Management Systems).

Is OpenClinica suitable for all types of clinical research studies?

OpenClinica is suitable for a wide range of clinical research studies, including observational studies, interventional trials, and registries.

Does OpenClinica offer support for users?

Yes, OpenClinica provides customer support, training resources, and a community forum for users to seek help and share best practices.

Can data in OpenClinica be securely stored?

Yes, data stored in OpenClinica is encrypted and secure to ensure patient privacy and confidentiality.

Is OpenClinica customizable for specific study requirements?

Yes, OpenClinica offers a range of customization options to adapt to the specific needs and protocols of different research studies.

Is OpenClinica cloud-based or on-premises?

OpenClinica can be deployed either in the cloud or on-premises based on the preferences and security requirements of the organization.

Does OpenClinica offer data visualization features?

Yes, OpenClinica provides tools for data visualization, reporting, and analysis to help researchers interpret study results effectively.


Elena Angelini

Elena Angelini

I'm Elena, your go-to software reviewer at UpdateStar and tech enthusiast. Whether you're a user seeking the latest software titles or software news I've got you covered. When I'm not diving into the latest software, you can find me exploring nature trails, camping under the stars, or competing in online multiplayer games. My reviews are designed to be fun, engaging, and packed with all the details you need to make informed decisions.

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