Synteract, a full service CRO based in Carlsbad, Calif., has implemented two Oracle Argus 7.0 modules to its pharmacovigilance technology platform, Oracle Argus Safety and Oracle Argus Interchange.

The information technology additions will enhance the safety data handling and electronic data efficiency, scalability and customization capabilities Synteract offers its biopharmaceutical clients conducting phase I-IV clinical trials as well as those with post-marketing pharmacovigilance needs. In conjunction, Synteract will now offer Oracle Argus Safety database hosting on a SaaS (software as a service) model for clients who would prefer specialists to handle implementation, validation and maintenance of their safety database and technology infrastructure. 

These two software modules provide a state-of-the-art technology backbone and cleaner interface in addition to strong redundancy and an efficient configurable workflow for Synteract’s clients. Key features and benefits of the system include:

• Multi-tenancy capability – facilitates management of multiple, compartmentalized Argus databases within one instance and allows for independent standardized configurations and greater workflow customization of each client’s environment;
• Data segregation – virtual private database technology supports flexibility, simplicity and security;
• Data exchange – offers electronic data exchange with partners and regulators with E2B+ functionality, supporting maximum efficiency and worldwide regulatory compliance;
• Cost-effective integration – the architecture of the software provides enhanced integration with other electronic and clinical databases.

“Our adoption of this software enables us to provide richer functionalities to our clients including more automation, customized workflow, and effective electronic exchange of data,” said Toby Odenheim, director of IT services, Synteract. “This will increase study efficiencies, allow for more seamless exchange of information and improve access to study information, all of which helps our clients get to decision points faster. Pharmacovigilance is enhanced and case processing and reporting of adverse events will proceed in a more efficient, streamlined manner.”

Synteract has experienced IT and safety professionals who can aid companies in the migration process from Oracle AERS or other databases to Argus.