All too often, bright medical luminaries have software forced upon them. Clinical sites may be finding all the patients, thinking big thoughts, but their tools are chosen for them. With each new trial, such sites receive another laptop, another program to learn.

So one wonders: what do penny-pinching academics and government scientists choose on their own dime?

One answer: OpenClinica from Akaza Research, out of Cambridge, Mass. The University of Connecticut just selected the package. Here’s a complete list of features of the Akaza platform, which has been downloaded 3,000 times. There are 800 registered users.

It’s all web-based, and easy to get data in and out of OpenClinica. The program conforms to the CDISC Operational Data Model standard. There is a wealth of both scientific and IT features. OpenClinica has special functionality for managing patient visit schedules, protocol compliance, and trial design. It combines elementary features of many commercial products.

One wrinkle is that it is a rudimentary clinical data and trial management system: OpenClinica can be used to manage data, sites, and trials. Users can create and manage case report forms. To quote the company’s website: “It facilitates protocol configuration, design of case report forms, electronic data capture (EDC), and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a strictly standards-based, extensible, and modular platform.” At many universities, the IT departments can get the free OpenClinica software up and running. The software really is available at no charge. If users need additional configuration or trial setup help, Akaza’s 12 employees will provide services on top of the software.

“We’re doing a lot of work in the academic space,” says Cal Collins, Akaza Research’s CEO. “It’s nice to see momentum for that starting to accelerate.” He’s young but previously co-founded e-guana.net, currently known as Isovera, and before that studied database systems and geographic information systems (GIS) at Harvard University, from which he graduated magna cum laude.

A new version of the software is being released on November 9. It will have enhanced EDC functionality, with better tools for managing data and tracking subjects, not to mention additional support for other data formats like SAS transport files.

At the federal government, Collins says, there is an open-source preference, especially inside the caBIG program that is establishing infrastructure for the trials run under the auspices of the National Cancer Institute. OpenClinica was born under an NIH grant. Johns Hopkins, Washington University in St. Louis, and the National Database for Autism Research (NDAR) are three of the up to 40 major nonprofits that are using OpenClinica.

OpenClinica is designed for more academic collaboration, he says, at a price that doesn’t break a professor’s budget. “We have been in situations where our costs were a third or a quarter of competing quotes,” Collins says. “We saw a need for a platform that had a lower costs of entry and a more fundamental business model that would support interoperability and transparency and community-driven development.”

Inside academia and government, Collins says, there is some wariness about the commercial clinical trial technology vendors. “On the high end, there are issues with cost and vendor lock-in—and the inability to customize things or get the solution exactly the way you want it. We really see the industry as in a fragmented situation. It’s a complex field. A lot of the fragmented solutions don’t talk to each other.”

In an age when anything running on Windows is a bit dubious from a security standpoint, Collins says OpenClinica can be less easily infected. “An open source platform has the potential to be more secure,” Collins says. “There are more eyeballs looking at the code and looking for holes.” The platform runs on the Oracle 10g and Postgre SQL databases, with ports to IBM’s DB2 and SQL Server in the works. The community of OpenClinica developers is strong, he reports, and self-sustaining with its own website.

Email Mark Uehling.

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