Oracle has introduced Argus Safety 7.0, an integrated global adverse events (AE) management and regulatory reporting offering.
The new offering enables health sciences organisations and contract research organisations (CROs) to maintain separation among and securely manage safety data from firms across the complex network of customers and business partners required for product development in the health sciences industry.
The offering eliminates the operational requirements associated with setting up and managing traditional safety offering in an enterprise, while maintaining security controls and facilitating compliance with US Food and Drug Administration (FDA) 21 CFR Part 11electronic record and signature requirements, said the company.
The Argus Safety 7.0 features new capabilities and centralised coding-dictionary management, which enable rapid set up and maintenance of new safety datasets, regardless of their source. The offering reduces the resources required for ongoing maintenance through a single, global user management and administration tool.
Oracle health sciences senior vice-president and general manager Neil de Crescenzo said product development in the health sciences industry is increasingly virtualised and complex, often spanning the globe and requiring the management of safety data from numerous co-marketing, in-licensing, and partner entities.
"Health sciences enterprises and their partners seek secure and efficient ways to manage this data across partners. Oracle Health Sciences Argus Safety 7.0 answers this call, enabling organisations to manage multiple datasets in a single instance while meeting 21 CFR Part 11 requirements. The end result is the ability to lower IT costs and reduce management and compliance complexity," Crescenzo said.
