OpenClinica 3.0 Features Preview – Part I

We have been working hard on OpenClinica 3.0 for the last 9 months and are getting closer and closer to a production release ready for use in live clinical studies. In the meantime, I wanted to talk about some of the new features over the next few weeks to let folks know what is coming.

OpenClinica 3.0 is sure to bring a lot of excitement to all users of the rapidly growing open source electronic data capture system. A lot of focus in this release has been put on the way trial sponsors use an EDC system and I’d like to point out some of the new features that should enhance their user experiences.

OpenClinica 3.0 will provide a new home page to study-level users providing key information about the progress of a study. These users will be able to see a summary of the subjects enrolled at each site compared to their expected total enrollment as well as the overall subject enrollment for the complete study. Also, these study-level users will be shown a count of the number of study events that are in a particular status. A summary for the number of subject statuses will be displayed so the study-level user can easily see how many subjects are signed, source data verified etc.

OpenClinica 3.0 will provide monitors a workspace to source data verify subjects and their data. The workspace will allow users to source data verify information collected at each visit one-by-one, or verify the information in a bulk process. These two options allow the monitors to perform remote source data verification daily for subjects in the study. Or, if the monitor has to be on site to review and verify information, he/she can go back to their hotel room and check-off verification for many subjects and events at once so they do not have to go one-by-one through every subject and event CRF.

The top-level navigation in OpenClinica 3.0 has been streamlined so site users of the application understand exactly what they have to do after they login. A new home page for investigators and clinical research coordinator users will show the number of queries assigned to them with a link to see every Query assigned them. The home page will show the 5 most recent queries to give the user an idea of what they need to respond to that day.

The new navigation points to the 3 main actions the site users should take. The “Subject Matrix” link will bring them to the new and improved subject matrix in OpenClinica. This matrix will allow users to easily add subjects, schedule events and even enter data from a single, powerful screen. The “Add Subject” link will bring them to a page where they can add a new subject to the study. “Notes & Discrepancies” will bring them to a page where they can see all the queries for their site and allow them to provide a response.

Above is just a small sample of the new features in OpenClinica 3.0. Like I said, I will plan on posting additional features once a week so be sure to check back often. In the meantime, please feel free to download the alpha2 at http://svn.akazaresearch.com/OpenClinica-3.0-distros/.

– Paul Galvin

How Open Source EDC Can Make Clinical Trials More Productive

Barbara Zwick, from the European clinical trial Evidence and Performance Blog recently published an interview with Ben Baumann, Director of Business Development at Akaza Research. The interview discusses how open source EDC (Electronic Data Capture) clinical trials software can help enhance product time to market and overall productivity of clinical trials. Here are some excerpts from the interview:

[BZ] Today’s big Pharma R&Ds are increasing their demand for efficiency and effectiveness. How are you facing this accelerating demand for speed to market?

[BB] There are a number of ways that OpenClinica can accelerate time-to-market. First, open source software can be much easier and quicker to evaluate and get up and running than proprietary software. People can readily install it and experiment with it. Potential adopters can readily inspect everything down to the source code and directly interact with other members of the OpenClinica community to get rapid, unbiased, real-world feedback.

In addition to a full set of EDC and CDM features one might expect in such a system, OpenClinica has  built-in features that give users the ability to set-up their own studies. Therefore, an organization can get a complete picture of how well the system will work for them before committing to use it.

In short, an organization can make a rapid and highly informed decision whether or not to use OpenClinica without having to go through lengthy vendor-biased demonstrations and negotiations, and rely on a vendor in order to get their studies configured appropriately.

[BZ] How can technologies serve to clinical trial performance, to minimize costs and time to market, and to allow rapid decision making? Are innovative EDC technologies, like your platform, more performant and focused on this specific need, rather than ‘old-fashioned’ EDC Solutions?

[BB] Aside from features of the product and benefits of the open source model described above, Akaza Research’s business model for support is designed to maximize productivity of clinical trials. Our support is comprehensive and highly flexible, so customers are able to obtain support packages tailored to their needs. In addition, our customers find our support to be of extremely high quality-after all support is our primary source of revenue.

Most of our support isn’t priced “per study” so clients are able to amortize their investment over numerous studies and don’t have to go through a lengthy contracting process for each new clinical trial they want to use OpenClinica for. This can really help to minimize costs and accelerate the set-up time for new studies.

[BZ] What are the pro and cons of an open source technologies versus a classical technology in the SaaS model?

[BB] First, OpenClinica is available under both a SaaS model and local deployment. Open source has a number of benefits over “classical” proprietary EDC systems. Here are a few examples:

–  Reduce vendor lock-in. Numerous proprietary EDC companies have failed and gone out of business. Open source products exist and evolve independently of any particular vendor, so if one vendor ceases to exist, there are others readily available to take their place.

–  Improved security. Open source software is frequently more secure and bug free than proprietary software. The open source code is continuously (and often intensely) scrutinized by large community developers and security experts. As a result bugs and security issues are found and fixed usually before they become real problems.

–  Readily customizable. Open source systems can be readily customized and extended–you don’t need to rely on a vendor who may or may not make the software modifications you need. If the system doesn’t work the way to want it to, you can change it.

–  Enhanced validation. Validation can be much more thorough with open source software. Buying proprietary software is like buying a car with the  hood welded shut-you don’t know what’s really know going on behind the scenes. Open source provides the highest level of transparency making it possible to truly validate a system from end-to-end.

Motivations for Contributing to Open Source

There are currently over 50 different types of open source software licenses approved by the OSI (Open Source Initiative).[1] One consistent theme these licenses share is that they encourage contributions from a community of users and developers. In numerous instances these contributions have proved significant and resulted in the establishment some of the most dominant technologies on the Web today, such as Apache, Linux, PHP, Java, MySQL, and SugarCRM. What are the factors that compel people to contribute to these projects? It seems the motivation comes from two sources: organizations and individual developers.

Open source can be strategic to organizations in several ways. For example, in the clinical research industry, contract research organizations (CROs) might incorporate an open source clinical data management system like OpenClinica into a complete clinical trial solution offered to their customers. Building OpenClinica into part a larger infrastructure may involve adding to or modifying the software in some way. Organizations doing this have a vested interest in contributing their software improvements back to the broader community in order to ensure these enhancements are supported in future distributions of the software. In this way, an organization can leverage a freely available software product for their own, customized purposes while helping to avoid “forking” the software into a unique product they might be stuck maintaining themselves.

While there may be solid business rationale for organization to use and contribute to open source, ultimately the software’s improvements come from individual developers. What are the motivations of individual developers to contribute to an open source project? Obviously, any company requiring its developers to work on an open source product for the company’s own purposes is providing one type of motivation for that developer to contribute. However, many open source projects largely comprise developers who purely volunteer their time outside of their capacity as an employee in a company. History has shown that over time these volunteers have produced some of the most paramount and sustained successes in the software world.

Take, for instance, the Apache project. Apache is the world’s most popular web server that began in 1995 at the University of Illinois, Urbana-Champaign and today powers nearly 50 percent of all websites worldwide.[2] While the software’s development is the result of an ongoing effort of volunteers, the community has evolved an organizational structure that appears to engender a motivational atmosphere among developers.[3] For example, a study at the University of California run by Il-Horn Hann and colleagues found that the salaries of Apache project contributors correlated positively with the contributor’s rank in the Apache organization and this ranking, therefore, is an indication of a developer’s productivity and market value to an employer.[4]

Many developers may of course contribute to an open source project out of intellectual curiosity or pure altruism. However, it seems the basic principals of economics can help to intensify the desire to contribute. Regardless of any one party’s motivation, it is undeniable that the meritocracy inherent in open source is an intriguing, if not highly effective paradigm for software development that is continuing to have a significant impact on modern computing.


[1] http://www.opensource.org/licenses/alphabetical

[2] http://news.netcraft.com/archives/2008/06/22/june_2008_web_server_survey.html

[3] The not-for-profit Apache Foundation helps to organization and coordinate the Apache open source community.

[4] I-H. Hann et al., “Economic Returns to Open Source Participation: A Panel Data Analysis,” unpublished working paper, Univ. of Southern California.

OpenClinica 2.5 Release

We are getting very near to the release version 2.5 of OpenClinica, representing a major milestone in the development of the popular open source software for electronic data capture (EDC) and clinical data management. The release contains a number of exciting improvements, including:

–    Rules engine for executing cross-field or cross-form edit checks and triggering notifications to users
–    Scoring calculations (derived values) in case report forms (CRFs)
–    New user roles for monitors and data managers
–    Improved monitoring/query management tools and discrepancy note reporting
–    Electronic signature capabilities
–    Ability to copy and edit previously created datasets
–    Improved auditing and logging capabilities
–    Simpler CRF upload
–    Improved support for CDISC ODM v1.3
–    Support for Oracle DB Backend out of the box.
–    Minor UI and application fixes from OpenClinica 2.2
–    Improved performance and scalability

Over the past 6 weeks the core development team has been putting OpenClinica through a rigorous, validated, QA and testing procedure. There are roughly another 3 weeks of documented testing ahead of us. If you would like to try the latest beta version of the application, please download it from http://svn.akazaresearch.com/OpenClinica-2.5-distros/.

Thanks to everyone in the community who has contributed to this release and provided feedback during the alpha and beta periods!

As we get closer and closer to the production release of OpenClinica 2.5, stayed tuned to this space for additional updates.