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Working in conjunction with Pfizer Inc. to help the medical community measure results of clinical trials, Oracle Corp. announced today the next iteration of its namesake Clinical Remote Data Capture.
Version 4.5 of Clinical RDC has upgrades in a number of areas, from advances in usability to support for international trials. Pfizer, of New York City, co-sponsored the development work for the new release and will license the software for its clinical trials.
The Clinical RDC software currently provides the capability for health care professionals to use a Web interface to enter patient data into a clinical trials database.
Version 4.5 adds additional functionality by integrating Adobes Portable Document Format [PDF] forms technology that allows data to be collected in computerized forms that are the same as the paper versions. The forms can be stored and reused—regardless of whether data is collected electronically or through a batch system.
At the same time, as data is entered it is validated against Oracles Clinical Data Management software. If there are any problems with the data, the user is identified. The data management system also provides an audit trail of changes—something that is required in medical trials by the Food and Drug Administration, Oracle officials said, in Redwood Shores, Calif.
A critical feature for clinical studies that version 4.5 provides is the ability for data from a completed study to be converted to PDF, which provides a certified copy of the data, as well as source data for the record.
The software is also available in Japanese, and can be translated back into English.