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ORACLE: LEO Pharma Goes Live on Oracle® Remote Data Capture Onsite 4.5.3

Upgrade Supports Company’s Efforts to Improve Clinical Trial Efficiency, Reduce Costs and Accelerate Drug Approval Submissions

/noticias.info/ * LEO Pharma A/S, a pharmaceutical company specializing in treatments for dermatological and vascular-related conditions, has upgraded to Oracle(r) Remote Data Capture Onsite 4.5.3, leveraging the application's new zero footprint and enhanced interface to help improve clinical trial site productivity and accelerate drug approval submissions to regulatory agencies.
* Oracle Remote Data Capture Onsite 4.5.3, the newest version of Oracle's electronic data capture (EDC) solution, helps life sciences organizations and contract research organizations (CROs) conduct clinical trials and studies more effectively and efficiently. It is fully integrated with Oracle Clinical, the industry's leading clinical data management system.
* The system's new zero footprint allows LEO Pharma's clinical trial investigation sites to rely solely on a Web browser without loading or maintaining additional software - streamlining system and site management.
* LEO Pharma also finds that trial investigators are opening report pages up to 70 percent faster with Oracle Remote Data Capture Onsite 4.5.3 than with the previous version of Oracle Remote Data Capture Onsite.
* Further, LEO Pharma anticipates that Oracle Remote Data Capture Onsite's improved interface and easy-to-navigate case report forms (CRF) will accelerate data entry at investigation sites and improve data accuracy - factors that contribute to faster data lock at the conclusion of a trial.
* The company also will use the system's expanded electronic reporting capabilities to facilitate submissions to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), by removing manual processes. 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 submission.
* LEO Pharma uses Oracle's automated trial randomization capabilities to securely and rapidly randomize participant treatments. It also leverages Oracle's automated unblinding capability at the conclusion of a trial, eliminating a previously labor-intensive process.
* The company first deployed Oracle Remote Data Capture in 2005, an implementation that helped it eliminate in-house data entry and remove expenses for printing, distribution and filing of CRFs, as well as decrease time from the last patient visit to database lock from six to 12 weeks down to one or two weeks. Today, LEO Pharma has more than 800 users of Oracle Clinical and Oracle Remote Data Capture.
* LEO Pharma is rolling out Oracle Remote Data Capture Onsite 4.5.3 to sites throughout the United States and Europe.

Supporting Quote

* "Oracle Remote Data Capture Onsite 4.5.3 provides us with powerful new functionality to help address two critical issues confronting the pharmaceutical manufacturing industry today - increasing the productivity and efficiency of investigation sites and accelerating the regulatory approval submission process," said Alastair Clewlow, Head of Clinical Data and Document Management, LEO Pharma. "We look forward to building on our previous success with Oracle Clinical applications."

Supporting Resources

* Oracle Remote Data Capture 4.5.3 Press Release
* Oracle Remote Data Capture 4.5.3 Data Sheet
* Oracle Clinical
* Oracle in Health Sciences
* LEO Pharma A/S
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