Heartfelt thanks to everyone who has supported the OpenClinica project over its relatively brief history. Our community now stands at over 10,000 registered members, representing a 3-fold increase in size over the past two years alone. With members in over 70 countries across six continents, open source is now a central part of the clinical trials software landscape. This is a major accomplishment that we should all be proud of.
While 10,000 may sound like a lot of people, there are still many within the clinical trials industry who do not understand the key concepts of open source. Other software categories have a high prevalence of open source offerings. For instance, when you look at database products (like MySQL, Postgres) and operating systems (like Linux, Android, BSD) there are numerous open source options. Open source is even widely prevalent in the EMR/EHR space, with OpenVista, and over 20 others to choose from.
As OpenClinica ushers the benefits of open source into the clinical trials space, it is instructive to periodically revisit the fundamentals of what exactly open source is.
What is open source?
Open source is a type of free software license–free as in “freedom,” not “beer.” It is not “freeware” and it is not “shareware.” More specifically, open source provides users with:
- The freedom to run a program, for any purpose
- The freedom to study how a program works and adapt it to a person’s needs. (Access to the source code is a precondition for this.)
- The freedom to redistribute copies so that you can help your neighbor.
- The freedom to improve a program and release improvements to the public, so the whole community benefits. (Access to source code is a precondition for this.)
There are numerous open source software licenses based on the above tenants and roughly 60 open source licenses have been approved by the non-profit Open Source Initiative. The OpenClinica Community Edition is distributed under the LGPL open source license.
Open source as a development model
The software development models around open source projects are typically characterized by transparency and collaboration within the community. Opening the product up to the community, allowing anyone to see the good with the bad, helps to quickly uncover problems and identify areas for improvement. Most open source projects will publicly maintain a project roadmap and defect tracking system. Release cycles of active open source projects tend to be early and often.
The result of such openness and transparency is software that is often more reliable and better performing than proprietary, closed alternatives.
What is professional open source?
Some people may think of open source projects as purely volunteer efforts. That is definitely not the case! While governance models vary from project to project, commercial enterprises have helped make open source consumable by ordinary people and businesses. For example, through its OpenClinica Enterprise Edition, Akaza Research provides support and regulatory assurances that help to minimize business risk and ensure success for organizations wishing to use OpenClinica in mission critical settings. Organizations can turn to Akaza to rapidly develop in-house expertise, obtain hosting and expert professional services, and ensure their OpenClinica systems and users are productive and satisfied.
A pervasive trend in software
Open source is everywhere. From the Firefox web browser to the most popular websites, everyone who uses the World Wide Web uses open source. As web-based technology, OpenClinica and the OpenClinica community are direct beneficiaries of numerous other open source projects. Those within the clinical trials space who recognize the significance of open source will be a step ahead of their colleagues.
- Ben Baumann, Co-Founder, Akaza Research, LLC
Want to be an OpenClinica Community Member? Members get free access to OpenClinica software downloads, Issue Tracker, email forums, and the OpenClinica Case Report Form (CRF) Library. Register at
 See Open Source Software Definition,
From the Free Software Foundation:
The SourceForge repository of open source codebases counts over 230,000 OSS projects.
Filed under: Industry Commentary | Tagged: clinical trials, clinical trials software, commercial open source, electronic data capture, Linux, open source, OpenClinica, openvista, oss, professional open source | 1 Comment »