April 12, 2007 | Early next year, Oracle will begin combining the best features of its JD Edwards, Siebel, and E-Business Suite product lines to form a new collection of web-based applications based on service-oriented architecture (SOA). It’s called, appropriately enough, Fusion.
SOA allows Oracle to knit together multiple services and present them to customers as a single integrated flow application, reducing the need for customization. Middleware for the Fusion project has been introduced. Oracle will continue to provide new releases of JD Edwards, PeopleSoft, and Siebel, says Dennis Constantinou, senior director of life sciences strategy and marketing.
Many life science companies globally run Oracle applications. Oracle’s Siebel applications for customer relationship management (CRM) have more than 160,000 life sciences users. All of the top ten contract research organizations run either Oracle Clinical or Oracle Clinical Trial Management System. And more than 300 companies have installed Oracle’s combined clinical data management and electronic data capture (EDC) solution. Oracle’s database is “ubiquitous.”
Last fall, four companies — Smiths Medical (U.K.), LEO Pharma A/S (Denmark), Ceva Sante Animale (France), and Steris Corporation (Mentor, Ohio) — publicly announced their choice of Oracle applications, infrastructure software, and services to help them accelerate and optimize new product development cycle time. With Oracle Remote Data Capture, LEO Pharma reported that processing time from last patient visit to database lock was slashed from 6-12 weeks to 1-2 weeks.
That its technology “supports the deployment of a variety of data types [including image files and chemical structure names] within a single environment” is just part of what Constantinou calls “the Oracle difference.” The company pioneered grid computing, whereby calculations can be run across a variety of servers simultaneously. Advanced algorithms embedded in the Oracle database allow for the detection of complex or hidden patterns.
By virtue of the Siebel acquisition last year, relationships with investigators can be managed similarly to relationships with customers, says Constantinou. Information about the types of trials that have been run and their associated costs, as well as patient and investigator recruitment, can be mined and used to select investigators for future trials.
Oracle is the only company of its kind to directly integrate adverse event and product complaints in a single repository, says Constantinou. Support for good manufacturing and business practices as well as integration with 21 CFR Part 11 requirements for electronic records and signatures are “native to the application.”
All trial-related information can now be brought together in a first-of-its-kind Life Sciences Data Hub, says Constantinou. This clinical data repository, in development since 2000, has been warmly received since its debut late last year. “Individuals can use it to execute more managerial decisions, since they’re not spending time reconciling information [between disparate systems].”
The Hub supports the “mission-critical task of integrating clinical and non-clinical data from multiple sources into a single environment where it can be analyzed, visualized, and reported by clinical researchers.” Boehringer Ingelheim is among several companies now piloting the Hub, says Constantinou.
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