OpenClinica – A Leading Innovative Open Source Clinical Trials Solution

Peter GroenOne of the top choices of Open Health News (OHNews) readers looking for information on 'open source' eHealth solutions in 2012 was OpenClinica.  OpenClinica has positioned itself as one of the world's leading open source clinical trials software for electronic data capture (EDC) and clinical data management (CDM).  OpenClinica was first released in 2005.

OpenClinica has been successfully used in thousands of clinical trials across some very diverse settings in over 100 countries. It has been used in studies involving 10 to 100,000 patients and in dozens of regulatory submissions for all phases of clinical trials. The OpenClinica Community now consists of over 15,000 members world-wide.

Background

OpenClinica was born out of frustration with existing proprietary electronic data capture (EDC) software that was inflexible, expensive, and difficult to consume. OpenClinica solved these problems by giving customers:

• A way to quickly deploy powerful software for running a clinical study regardless of the study's size, scope, language, budget, and other factors.
• The freedom from becoming locked-in to a single vendor
• The freedom to tailor an EDC solution to ones particular needs.

Today, OpenClinica provides the industry with one of the more powerful software solutions for capturing and managing clinical trial data.  It allows you to build your own studies, design electronic Case Report Forms (eCRF), and conduct a range of clinical data capture and clinical data management functions.

Major Features

OpenClinica believes that flexible software built on 'open standards' and 'open architectures' can best meet some of the most significant challenges facing clinical research today. It supports Good Clinical Practice (GCP) quality standards and guidelines.

OpenClinica comes in both a Community & an Enterprise edition.

• The OpenClinica Community edition is freely available for all to use.
• The OpenClinica Enterprise edition has additional capabilities and is commercially supported.

* Download the community edition at https://community.openclinica.com/project/openclinica

OpenClinica provides a range of consulting services related to setting up research studies and conducting clinical trials, in addition to support services such as hosting, training, maintenance, and tailored software enhancements.

Feature Highlights

• A robust and scalable technology infrastructure developed using the Java J2EE framework and powerful PostgreSQL database.
• An intuitive interface for subject enrollment, clinical data capture, validation, and query management. 
• As a web-based software solution, all users need is a PC, browser, and an Internet connection.
• Tools for clinical data management, data cleansing, and site monitoring. 
• Assistance in configuring study protocols: electronic Case Report Forms (eCRF), edit checks/rules, users, and study event definitions, and more. 
• Automated and manual capabilities for import, export, and data interchange data with other systems in a variety of formats.
• Rules engine performing advanced validation of study data and define automated actions within the system.
• Administrative tools for overall system oversight, auditing, configuration, and reporting.
• Security: setting up roles, access privileges, user authentication & passwords, electronic signatures, SSL encryption, de-identification of protected personal data, and a comprehensive set of auditing tools.

* See https://docs.openclinica.com/3.1/openclinica-user-guide/overview-openclinica

Recent news items in Open Health News (OHNews) related to OpenClinica

• OpenClinica chosen for use in Cardiovascular Clinical Trials
• Queensland Clinical Trials & Biostatistics Centre Selects OpenClinica Enterprise Clinical Trial Software
• MICHR Introduces “Mi-OC” Do-It-Yourself Version Of OpenClinica Clinical Trial Management Software
• OHN 2012 Readers Choice: Most viewed 'Open Source' eHealth software
• OpenClinica Global Conference Features Industry Thought Leaders, New Release
• Breaking Barriers: Forging a New Model for Clinical Development
• OpenClinica Announces 2012 Global Conference

Conclusion

Finally some closing observations, thoughts, links for our readers to follow up on if they want to know more about OpenClinica. 

• As OpenClinica technology is deployed into more sophisticated and diverse environments, demand increases for features, scalability, usability, and robustness. Check out this presentation on OpenClinica Roadmap given at the OpenClinica Global Conference in 2012.
• Check out the OpenClinica Blog for information on upcoming releases, projects, community discussions, cloud solutions, and much more.
• For those who want to see a self guided or video recorded demo of OpenClinica – go to https://www.openclinica.com/self-guided-demo
• The OpenClinica web site also provides access to an 'open' Virtual Community Forum to share ideas, promote collaboration, and help determine the future direction and development of the system.

Here at Open Health News (OHNews), we expect to hear a lot more about OpenClinica in the coming years and will be reporting on the company, the community, and their innovative 'open' solution.

Peter Groen, Senior Editor, Open Health News (OHNews)