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Oracle Introduces Oracle(r) Remote Data Capture Onsite to Help Life Sciences Organizations Accelerate and Simplify Clinical Trial Data Collection


REDWOOD SHORES, Calif., 19-SEP-2006 Oracle today introduced Oracle® Remote Data Capture Onsite, a next-generation electronic data capture (EDC) system designed to accelerate and simplify the collection of clinical data and the deployment of EDC studies at clinical trial investigative sites, helping to improve site personnel productivity and trial data accuracy.

Individuals at clinical trial sites tasked with collecting data must be able to locate and enter patient case report form (CRF) data quickly. Time wasted searching through records takes away from site personnel’s primary task – collecting timely and accurate patient data. Oracle Remote Data Capture Onsite, a new interface that can be applied on top of Oracle Remote Data Capture v4.5.1, streamlines navigation to CRFs for accelerated data display and/or update.

“The environment at many clinical sites is unpredictable, with patients coming in for unplanned visits that require on-the-spot data collection,” said Mychelle Mowry vice president for Global Health Industries at Oracle. “Oracle Remote Data Capture Onsite helps busy clinical trial site personnel manage this unpredictability by accelerating patient identification and data entry. Site personnel can easily locate and update patient information, as well as add unplanned CRF pages and/or patient visits by quickly searching on the patient or drilling down within the study hierarchy.”

Oracle Remote Data Capture Onsite provides an extremely intuitive data entry interface, allowing site personnel to interact with CRFs electronically as if they were working in a native paper environment. The system also performs robust online edit checks instantaneously in the data entry environment, invoking a discrepancy management module from the CRF to capture, route and resolve discrepancies, when necessary.

The Onsite interface presents CRF(s) as icons, which graphically illustrate the status of the CRF data – clean, verified, and/or approved – to site personnel. This feature allows Onsite users to perform a fast, visual inspection of the status of each report form.

Oracle Remote Data Capture Onsite helps further enhances clinical site productivity by enabling electronic messaging between users, which allows personnel to verify and approve patient data as quickly as possible. Users can conduct verifications against a group of CRFs or individually, as well as back up approvals with electronic signatures to assist in complying with regulations regarding Electronic Records and Electronic Signatures (21 CFR Part 11).

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