Clinical

PRODUCT DESCRIPTION

Why Oracle for Clinical Applications?
Without clinical data that's well organized, easily accessible, and thoroughly documented, the value of a drug may not be fully realized. Moreover, disparate databases from a variety of systems make it difficult to obtain a comprehensive view of important clinical data. While major pharmaceutical companies have tried to develop in-house integrated solutions, they seldom fulfill overarching data management needs.

Oracle's suite of applications for clinical development provide a streamlined system for managing large volumes of patient data collected during clinical trials. These applications offer features for modeling any kind of clinical study, automatically storing components for reuse in a flexible global library. Oracle's suite of clinical applications provide powerful study layout and design features, comprehensive edit check facilities, sophisticated tracking, full analysis and reporting capabilities, as well as an integrated remote data collection facility for site-based entry.

Integrate and Streamline
Oracle has built the most comprehensive suite of applications for clinical development. The products, Oracle Clinical, Oracle Thesaurus Management System, Oracle Adverse Event Reporting System, Oracle Life Sciences Data Hub, can be deployed individually or together allowing for incremental growth for existing customers or a full eClinical suite for new customers. All the applications have been designed with integration in mind. Oracle Clinical Applications Let You:

Streamline Clinical Development Information Management
Oracle Life Sciences Data Hub is an integrated environment for clinical data, which let life sciences organizations make better decisions based on more accurate and timely information. It can enhance productivity, aid compliance, and reduce risk across clinical development. Oracle Life Sciences Data Hub supports the mission-critical task of integrating clinical and nonclinical data from multiple sources into a single environment where it can be analyzed, visualized and reported on by clinical researchers.

Boost Productivity
Oracle Clinical allows you to improve data capture processes, increase levels of efficiency, and boost overall productivity. Through a simple and full-featured interface, investigators, monitors, and site coordinators can enter and clean clinical data, monitor trial progress, and track source-document verification.

Manage More Than 100 Dictionaries
Oracle Thesaurus Management System (TMS) can readily manage more than 100 dictionaries, and is designed to handle the complexities of the Medical Dictionary for Regulatory Activities (MedDRA), including the multi-axial hierarchy of a dictionary.

Monitor Adverse Events
Oracle Adverse Event Reporting System (AERS) gives pharmaceutical companies the power to store and monitor all serious adverse events so that safety concerns can be addressed before a drug reaches the market. Oracle AERS is also the only safety system that is fully integrated with the leading clinical data management System--Oracle Clinical.

Perform Accurate Remote Data Capture
Oracle Remote Data Capture (RDC) is built upon the same data model as Oracle Clinical. This feature streamlines data entry processes because both Oracle Clinical and Oracle RDC use the same data entry screens and edit checks. Mixed mode trials are greatly simplified because data entered through RDC is stored in the same tables as the data entered through Oracle Clinical. Moreover, there's no duplication of effort because a study need only be defined once, then simply made available to both applications.

Carefully Manage Clinical Trials
Siebel Clinical Trial Management System activity management provides clinical research associates with a powerful tool to actively maintain contacts with sites, and to manage issues through to resolution. Using Siebel Clinical Trial Management System trip report tool, clinical research associates can schedule site visits based on investigators availability, site enrollment, or completed work. Prebuilt visit report templates help drive consistent business processes based on regulatory mandates and companies' standard operation procedures.

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