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Oracle has rolled out version 3.1 of its Health Sciences Clinical Development Center application to help standardize, automate and quicken the flow of data during clinical drug trials.
Clinical Development Center is a type of clinical data warehouse application, a health care database that stores clinical data from multiple locations.
“The Oracle Clinical Development Center 3.1, via its new integration capabilities and standardization enhancements, enables organizations to further accelerate data aggregation and reconciliation, streamline preparation for analysis, automate the downstream analysis process, and ensure control and compliance,” Neil de Crescenzo, senior vice president and general manager for Oracle Health Sciences, said in a statement.
Bringing drugs to market in a safer, faster and more cost-effective way has long been a struggle for the pharmaceutical industry, and Clinical Development Center helps pharmaceutical companies manage the data that come from widely distributed sources, according to Oracle.
“As clinical trials continue to expand in scope, complexity and cost, trial sponsors and contract research organizations require solutions that enable them to efficiently aggregate and process rapidly growing volumes of clinical trial data emanating from multiple sources,” de Crescenzo said.
To get new drugs approved, health care companies need to acquire clinical data from various sources such as laboratories or investigative sites, perform a statistical analysis on it and submit reports to regulators, whether it’s the FDA in the United States or the EMA (European Medicines Agency), Martin Young, vice president of strategy, for Oracle’s health sciences global business unit, told eWEEK.
Being able to incorporate data from multiple sources and various file formats such as SAS, ASCI, XML or DBMS can improve the efficiency of the drug trial process and provide the statistical basis to satisfy regulators’ requirements more effectively.
“This system helps them pull all of that data together, do all of the statistical analysis of that data and then produce reports that verify or disprove the results of that drug,” Young explained. “It’s automating a whole stream of activity-and making it hands off-that people had to get in to do themselves,” Young said.
Software such as Clinical Development Center allows the pharmaceutical industry to become more virtualized and manage data from elsewhere, he said. This need to virtualize data from multiple sources has been building up over the last three years, according to Young.
The software pretests and validates data libraries to help researchers standardize information and reuse data models for multiple studies without having to create a new test each time, Young said.
New triggers for data execution help speed up the process of data analysis and increase its accuracy, he said. In addition, the software sends alerts to let the statistician know whether or not data is up to date.
Version 3.1 of Clinical Development Center, announced on March 29, can incorporate data from Oracle’s InForm SAAS (software as a service) application. InForm automates data delivery and provides direct links to data sources.
The new version also features added compatibility with Medidata’s Rave clinical data management platform to automate setup of studies and downloading of data.
In addition, version 3.1 aids automatic loading of metadata from studies by linking up with Oracle’s Siebel Clinical Trial Management System software, which allows clinicians and researchers to manage and track complex data, Young said.