The life science business has to be able to master the delicate equation of patient safety and cost control, while complying with regulations. The implementation of a safety system to manage adverse events (AE) is essential. For example, Oracle Argus Safety Suite helps you to enable regulatory compliance and proactively deal with early signal detection. A business analysis will help you optimize business processes and enhance the impact of the safety system investment.
NNIT’s Safety Business Analysis addresses the critical issues the life science business is facing. We have a holistic approach to the business and take safety, as well as non-safety, processes into account. We have the necessary business knowledge and process experience within pharmaceutical development and marketed products to help you identify the optimal safety system for your organization. Furthermore, we have the technical capabilities to ensure seamless integration with your existing systems and SOPs.
Deployment of the safety system with the required validation activities and documentation
NNIT has a proven track record in implementing, hosting, and supporting safety systems for a number of major pharmaceutical clients. We offer a number of safety systems, including the Oracle Argus Safety Suite - a configuration-based pharmacovigilance safety suite - that provides complete case management and regulatory reporting functionality.