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.

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