Open-source EDC software gaining ground
Akaza launched version 2.5 of OpenClinica last month, an event which has prompted a spike in the number of downloads of the software to a current total of more than 16,000. That is a huge advance in the last couple of years. OpenClinica debuted n 2005 and by August 2006 had just 2,000 downloads.
CEO Cal Collins said recently that the software is in use at more than 150 sites around the world, including biotechnology and pharmaceutical companies, contract research organisations, academic and medical centres and government agencies.
“Users should be able to choose a professional-grade EDC solution without having to be worried about becoming locked into an inflexible system,” said Collins.
The open-source path taken by Akaza is already well-trodden by other software developers, which see the benefit of making packages available for free in the hope that it can make revenues from providing support products and services.
The best example is probably the various versions of the Linux operating system, which is seeing an acceleration in usage as a viable and free alternative to Microsoft’s Windows and other paid-for operating systems such as Apple’s OS X. Others include Mozilla’s Firefox browser and even the technology underlying Wikipedia.
OpenClinica is released under an open-source license, which means that the code can be viewed and customised by users, so there is an active community of people adding to the source code and extending its functionality beyond its proven features in subject enrolment, data capture and data management.
“OpenClinica provides greater productivity for clinical research operations,” said Collins. “You can transform paper-driven processes, or increase the productivity of existing eClinical work, all in a 21 CFR 11 compliant environment.”
While initially targeted at academic institutions and other organisations that may not have the resources to select a commercial EDC system, it seems that more and more drugmakers are signing up to OpenClinica.
And with the resources available to many pharmaceutical companies it seems likely that what is driving that trend is not the system’s relatively low cost, but the network of developers behind it that are keeping the project evolving with new functionalities and refinements continuously becoming available.
“Buying proprietary software is like buying a car with the hood locked shut by the auto dealer,” according to Collins. “Open source opens the hood and allows car owners to inspect and work on the engine themselves.”
