Oracle introduces version 4 of pharmaceutical applications suite, Pfizer to implement
The program is designed to allow for all of its products to be run over a company's Intranet or the public Internet using the Oracle8i database. The Thesaurus Management System (TMS) supports the set-up of medical dictionaries such as MedRa and WHO Drug, by loading the dictionaries from source files, and then classifying investigator terms against the dictionaries. The system can be used as a standalone program or in conjunction with any other system for clinical data management or adverse events.
The version 4 program is designed to enable the ability to manage multiple versions of a dictionary over time, allowing user-configurable workflow during the classification process, flexible encoding algorithms with language-based searches and an enterprise dictionary browser.
The Oracle Clinical program is a clinical data management system to developed to support study design, randomization, the entry and management of data, the handling of lab data, data validation and derivation capabilities and the extract of data for analysis. The version 4 includes a new menuing system, a Java-based layout editor for data entry screens, the ability to designate allowable character codes in numeric or data fields, an enhancement to the discrepancy management system and facilities for performing mass changes of data.
In addition, the Remote Data Capture (RDC) program is a new facility designed to allow for the entry and management of data over the Web. The system supports data entry and discrepancy management, data searches, a system for broadcasting news to remote users and capabilities for electronically recording source data verification and investigator approval. The system is fully integrated with Oracle Clinical.
"We look forward to deploying version 4 globally at Pfizer to take advantage of the new capabilities and simpler support offered by the Web version of Oracle Clinical," said Ira Stoler, Vice President of Global Clinical/Regulatory Informatics at Pfizer. "Across an organization as large as Pfizer, this represents a great advance in reducing our internal support costs and the complexity of our technical infrastructure."
"For the first time, staff at an investigative site can use a friendly front-end system that is completely integrated with an industrial-strength data management system," said Sohaib Abbasi, Senior Vice President of Oracle's Tools Division. "Processes that used to take weeks may now be done in minutes."