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 fulfilled."

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.

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 patients.

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.

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.