OpenClinica 3.0 Features Preview: Part III

Welcome to the 3rd and final installment of the OpenClinica 3.0 features preview!  This post covers the new Web Services interface that is part of 3.0 and the job scheduler that can be used to automate Data Import and Data Export jobs.

OpenClinica 3.0 allows for programmatic interaction with external applications to reduce manual data entry and facilitate real-time data interchange with other systems.  The OpenClinica web services interface uses a SOAP-based API to allow the registering of a subject and scheduling of an event for a study subject.

OpenClinica provides a WSDL (Web Service Definition Language) that defines a structured format which allows OpenClinica to accept “messages” from an external system. For example, an EHR system could register subjects for a study in OpenClinica without direct human intervention. At the same time, the EHR could also be programmatically scheduling study events for these subjects. More information about the OpenClinica API can be found on the OpenClinica developer wiki.

An early reference implementation conducted by clinical lab Geneuity used the API to create a web service which inserts data programmatically into OpenClinica CRFs directly from laboratory devices. See the post by Geneuity’s Colton Smith below.

Another major productivity tool in 3.0 is the introduction of a Job Scheduler for automating bulk data import and export.  With this feature users can define a job that will generate an export at a specified time interval.  The Jobs Scheduler can also be configured to regularly scan a specific location for CDISC ODM files and run data imports when a new file is available. This feature can be particularly helpful in automating routing functions, such as the incorporation of lab data into OpenClinica from an external system.  The lab data does need to be in a valid CDISC ODM format (this can be accomplished via another great open source tool called Mirth), but it does save a person from entering data in two applications separately.

At time of this post, OpenClinica 3.0 is currently released as a beta3, but the production ready application is soon to follow. The application is passing through the highly rigorous strictures of our quality system (think Navy Seals training for software) and the output will be fully validated and ready of use in roughly a month. Needless to say, I, and everyone else here at Akaza is very excited to be so close to releasing 3.0. It is already quite clear that this release will have a momentous, positive impact on the community.

eCTDs to get more important in 2008

In this past year, we worked hard to update the Electronic Data Capture facilities of OpenClinica; we also worked very hard to get OpenClinica internationalized, so that it could reach a wider audience in the OSS clinical research world.

One of the things that will be on the horizon for us now is improving data export.  And now is definitely the time for that; according to ClinPage, as of Jan 1st 2008 the FDA will accept electronic regulatory submissions in the form of the Electronic Common Technical Document (eCTD) only.

OpenClinica currently provides reports in several different formats, including the CDISC ODM format in XML, and we’ll be working to improve that over the coming months.  The change in the FDA’s standard is paving the way for all organizations, big and small, to find a way to submit documents electronically, and we hope OpenClinica will be able to play a part in providing a low-cost alternative to many organizations.  As the above ClinPage article points out:

….the major pharmas made the transition to electronic submissions years ago—in some cases, as early as the 1990s. They quickly earned a return on investments in better regulatory document systems, even though the technology was far more expensive then.

The situation is different for small pharmas and biotechs today, Perry says. They typically lack the manpower to attend to both routine regulatory work and manage the transition to a new system. He adds: “The purchase price of the system is not the obstacle. It is implementing. The smaller you are, the more desperately you need one of these, but the less people you have to implement them.”

Even as IT budgets may be getting smaller, as George Laszlo writes, the need to add the EDC system (and other systems) to an existing lab is getting bigger.  Through this blog, we hope to chart how health IT, and especially clinical research needs, can be met by implementing OpenClinica as a flexible, lower-cost solution.