Using business intelligence for strategic advantage in REMS

Abstract

The FDA has mandated Risk Evaluation and Mitigation Strategy programs to manage risks associated with drugs. REMS programs comprise elements to assure safe use (ETASUs), and companies need to implement some (least restrictive) to all ETASUs (most restrictive) required by the FDA. Implementing ETASUs can require companies to perform a number of different activities from better educating customers and end-users to continuous monitoring of customers and end-users for risk of adverse events. In performing activities required for ETASUs, companies need to acquire, create and manage significant amounts of data on their customers, end-users, product use, distribution and so on. If effectively done, these data can be married with other data from customer relationship management, marketing campaigns and so on to create a business intelligence goldmine to support and enhance marketing and sales effectiveness, and business operations.