Oracle updates applications for clinical trial management, adverse-event reporting

May 9, 2011
Pharmaceutical Commerce, Pharmaceutical Commerce - May/June 2011,

Emphasis is on operating a single instance for multiple clients

Oracle has a new version, 7.0 of Argus Safety, the business it acquired a couple years ago, and has also updated Oracle Clinical, Oracle Remote Data Capture and Oracle Thesaurus Management System, which collectively help drug sponsors and contract research organizations (CROs) to manage pre- and post-commercial clinical studies and data management. Both the Argus Safety and Clinical products are now interfaced with Oracle 11g, the latest version of its database management technology; additional the Oracle Clinical products have “seamless” integration with the Siebel Clinical Trial Management System, which provides planning and overall management of clinical trial processes.

Adverse event reports (AERs) are a requirement of any manufacturer of approved drug products; the task calls for systems that can efficiently record relevant data about a reported event, and then present those data for signal detection of potential health risks in drug use. “The trend has been for manufacturers to outsource this function, often to CROs, who then are called on to manage the safety program of multiple clients,” says Martin Young, VP of product strategy. “Argus 7.0 has been designed with this multiple-client environment in mind,” containing security and workflow procedures that allow this function to be run from a single instance of the application. Quintiles, an Oracle user, can now provide a “validated, end-to-end lifecycle safety solution which is available entirely as a cloud-based platform,” according to Richard Thomas, CIO at the firm.

The clinical tools have been redesigned to enable adaptive clinical trials, in which the parameters and endpoints of the trial can evolve as the trial progresses; adaptive trials are one of the methods researchers are using to extract more value, more quickly, from the clinical research process. The integration with Siebel is carried out via an Oracle Application Infrastructure Architecture process integration pack (PIP), Oracle’s method of unifying the wide array of developed or acquired software tools it markets.