Operational Model for Pharmacovigilance
Global Health Regulatory Agencies mandate all Pharmaceutical and Modern Drug Discovery companies to collect, process, and report adverse events. Organizations failing to achieve 100% compliance may face penalties or face drug withdrawal from the market.
In the quest to discover and launch novel drug molecules and delivery systems, Pharmaceutical companies face a trade-off between Efficiency, Quality, Compliance, and Innovation. Resources with robust domain knowledge are not readily available. If internally sourced, the cost of maintaining niche resources & infrastructure is very high. Processing Adverse Event (AE) data adds to the cost pressure as case volume is variable and fluctuates as per various factors like age group, medical history, seasonal change etc.