Oracle Introduces Remote Data Capture Onsite 4.5.3 With Extensive New Functionality for Investigative Site Personnel

Advanced Electronic Data Capture Solution Helps Life Sciences Organizations

Conduct Trials More Efficiently and Effectively

Mar 03, 2008, 00:00 ET from Oracle

    BARCELONA, Spain, March 3 /PRNewswire-FirstCall/ -- DIA 20th ANNUAL
 EUROMEETING, Oracle today announced the introduction of Oracle(R) Remote
 Data Capture Onsite 4.5.3, the newest version of the company's electronic
 data capture (EDC) solution designed to help life sciences organizations
 and contract research organizations (CROs) conduct clinical trials and
 studies more effectively and efficiently. This significantly enhanced
 version of Oracle's EDC application features new functionality to meet the
 needs of trial sponsors as well as investigative site personnel. It is also
 completely Web based -- with zero client footprint for the HTML data entry
 window -- to enable improved global access and performance.
     Investigative sites are essential to the success of a clinical trial.
 The pharmaceutical industry is increasingly focused on providing
 investigative sites with tools that enable more rapid and accurate data
 entry. The most recent version of Oracle Remote Data Capture Onsite
 supports this requirement, providing new functionality, such as spreadsheet
 displays of multiple case books as well as robust edit check capabilities,
 intended to help busy investigative site personnel efficiently capture
 accurate data.
     "Clinical trial sponsors are realizing considerable benefits from their
 investment in EDC deployment; but the requirements of the investigator
 site, EDC's most important end-users, historically have largely been left
 unmet," said Chris Connor, senior research analyst at Health Industry
 Insights, an IDC company. "Investigators are now pushing back on
 sponsor-centric EDC solutions. The demands of patient care coupled with the
 increasing responsibilities of clinical research are stretching
 investigators to their limits. As a result, the industry is quickly
 approaching a tipping point in its ability to successfully recruit and
 retain physicians as investigators in clinical trials. Oracle Remote Data
 Capture Onsite 4.5.3 represents a fundamental shift toward helping to
 ensure that the needs of EDC's most important stakeholders are being
     Oracle Remote Data Capture Onsite 4.5.3 is integrated with Oracle
 Clinical, the industry's leading clinical data management system, and is an
 integral component of Oracle's extensive suite of clinical trial management
 applications. In developing functionality for the new release, Oracle
 worked closely with a group of customer advisors -- which included
 representatives from Boehringer-Ingelheim, Bristol-Myers Squibb, PPD, Inc.,
 a global contract research organization, and Pfizer.
     Rapid Navigation
     Investigative personnel at clinical sites need a system that allows
 them to quickly locate patient visit and case report forms (CRFs). Time
 spent searching through records or waiting for downloads takes away from
 the primary task of site users, which is to collect timely and accurate
 patient data.
     Oracle Remote Data Capture Onsite 4.5.3 provides users with rapid
 navigation to patient CRFs for data entry and review, presenting site
 personnel with a sortable, searchable list of patients for their site.
 Patient icons quickly communicate status -- with or without data entered
 and with or without active discrepancies. The user simply selects one or
 more patients then navigates to the casebook spreadsheet for the selected
     Different user groups with different responsibilities use Oracle Remote
 Data Capture Onsite 4.5.3 in various ways. A multi-purpose tool, Oracle
 Remote Data Capture Onsite provides tailored interfaces based on job
 function -- allowing users to work effectively with a tool that is designed
 to meet their unique job requirements.
     Improved Patient Data Report
     Oracle Remote Data Capture Onsite 4.5.3 also features a new Patient
 Data Report that offers significant performance gains and is better
 tailored for use in electronic submissions. The Patient Data Report
 provides a single PDF file of all CRFs entered for a single patient and
 presents data in the same form layout used for data entry. At the
 conclusion of a study, Patient Data Reports, coupled with audit trail and
 discrepancy information, provide a certified copy of the data for the
 investigative sites, and supply the data portion of the eventual
 submission. The new Patient Data Report also provides substantially
 improved performance for large-scale trials. To help with electronic
 submissions, the report includes PDF bookmarks and other features specified
 in U.S. Food and Drug Administration (FDA) guidelines.
     Accuracy Counts
     Timely data entry is valuable only if data is recorded accurately in an
 equally timely manner. To facilitate this process, Oracle Remote Data
 Capture Onsite 4.5.3 features a robust system of edit checks to help ensure
 data accuracy and integrity. The system allows users to check accuracy at
 various stages of the investigation process. First, the system conducts
 edit checks upon data entry, flagging errors (discrepancies) so that site
 users can correct problems almost immediately. The patient validation
 function then executes more complex edit checks, typically relating to data
 values that do not correlate across CRFs. Finally, if patient validation is
 not executed, regular (nightly) study-wide batch validation raises the
 discrepancies that the patient validation would ordinarily catch.
     "Data validation issues can significantly delay completion of the
 clinical trial phase as well as database lockdown," said Jim Streeter,
 Executive Director EDC, PPD. "The newest version of Oracle Remote Data
 Capture Onsite offers increased automation by providing edit cache and
 validation at several steps in the process. This unique functionality
 yields cleaner data, faster -- enabling CROs, like PPD, to help our clients
 complete trials faster and accelerate time to market for new products."
     "EDC systems offer a powerful tool to help life sciences organizations
 improve data quality, accelerate data collection, and reduce clinical phase
 costs," said Neil de Crescenzo, Group Vice President, Healthcare and Life
 Sciences, Oracle. "To help organizations reap the full potential of EDC
 technology, Oracle has created a system that not only provides robust
 capabilities for trial sponsors but also addresses the unique needs of
 investigative site personnel, who are tasked with collecting accurate data
 while managing patient care. Oracle Remote Data Capture Onsite 4.5.3 is
 testament to Oracle's continued commitment to developing applications that
 help our life sciences customers address their pressing business
 challenges, including containing costs, ensuring safety and accelerating
 time to market."
     Oracle Remote Data Capture 4.5.3 is generally available today. Terms,
 conditions and restrictions may apply. For more information on Oracle
 Remote Data Capture go to:
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