Pharmacovigilance is becoming a more pressing issue in the drug and device cycle, mostly due to increased regulations by the FDA and EMA which are looking to increase patient safety in both clinical development and post-market use. Companies engaging in clinical development need a proper pharmacovigilance system that can manage case processing and vast amounts of data.
ARITHMOS discusses the importance of keeping systems up-to-date and the risks involved in running discontinued systems. Specifically related to pharmacovigilance and end users, ARITHMOS addresses issues associated with using Oracle AERS and Trace, two pharmacovigilance systems that will move from premium support to sustaining support (AERS 4.7 in January 2015, Trace in August 2016) meaning support services are limited and migration is recommended.
During the life cycle of a product, manufacturers produce patches to ensure security, and therefore when the life cycle of a product ends, the manufacturer discontinues full support (or in Oracle’s case, premium support). More importantly and even riskier for end users in the clinical development sector, this could put companies in danger of non-compliance with industry standards and regulations.
In the case of discontinued or outdated software, the service provider can’t keep systems up-to-date and recommend migrating to new versions or platforms.
Smart Strategy: Migrating to Oracle Argus Safety Suite
Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. Oracle AERS premium support will end in 2015, and therefore ARITHMOS recommends a data migration project to Oracle Argus Safety. Argus Safety is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Gold Partner, ARITHMOS can offer Oracle Argus Safety Version 7 as well as migrate safety data from legacy or discontinued systems.
As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migrating from a discontinued system starts with a Business Requirement and Configuration analysis through to validation testing and reports.
Due to increased regulation on safety data and the need to improve data quality, ARITHMOS can guarantee real-time and customized reporting solutions for Oracle Argus Safety including integration with Oracle Business Intelligence.