Oracle Corporation has announced a major new release of its industry-leading clinical data management solution, Oracle Clinical. Designed to support the management of data collected during clinical trials, Oracle Clinical enables pharmaceutical companies, biotechnology companies and contract research organisations to implement company-wide standards for clinical testing, data collection, and data analysis. By standardising study designs and data management protocols across all divisions of a company, companies using Oracle Clinical can significantly improve the efficiency of clinical data management activities in all phases of clinical development, thereby reducing clinical development costs and expediting time-to-market for new products. Oracle Clinical was developed in collaboration with leading pharmaceutical and clinical testing organisations to meet their specific needs. "Two years ago we launched a major initiative to select the next-generation architecture for our clinical data management," said Ira Stoler, Executive Director, Corporate Clinical and Regulatory Systems, Pfizer, Incorporation. "We chose Oracle Clinical not just because of its technical leadership, but also because of Oracle`s demonstrated ability and commitment to work with us to evolve Oracle Clinical into a world-class application. I am extremely pleased with the degree of interaction and co-operation between our two companies." New features in Oracle Clinical Version 3.1 directly improve the speed and efficiency in producing analysis-ready data collected during clinical trials. It includes a major enhancement of the validation and derivation procedure subsystem with improved performance and enhanced capabilities. Procedures can now be stored as database objects for improved performance and reusability, thus reducing the time to execute and develop complex data validation and derivation procedures. Data extraction has been enhanced to provide complete flexibility in developing custom views of data for analysis. This includes cross-study views for merging data from multiple studies for integrated analysis and the Ability to easily create custom searches and reports. Data can optionally be extracted into tables for improved query performance. Oracle Clinical Version 3.1 includes an enhanced batch loading facility that allows users to load data from a variety of sources and formats. It also includes expanded help systems and documentation to reduce the time To learn and effectively use the application. The documentation has been completely revised to be online and HTML-based, and companies can now smoothly integrate their own custom documentation and processes, thus easing the system validation process required by regulatory authorities. Additional features have been added to facilitate integration between Oracle Clinical and other systems. These include page-level tracking and a get-image function to permit integration with document imaging systems, and an extract feature to facilitate loading study data into analytical and viewing tools such SAS/PH-Clinical. "Oracle Clinical specifically meets the needs of today`s clinical development environment," said Peter Forsyth, Applications Oracle South Africa. "Its advanced architecture and richest of features help drug companies reduce the time from discovery through regulatory approval and improve efficiency in managing post-marketing trials."
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