Oracle has introduced Health Sciences Clinical Development Center 3.1 to allow researchers to process clinical trial data quicker from multiple sources.
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
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
To get new drugs approved, health care companies need to acquire
clinical data from various sources such as laboratories or
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
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
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.