The Orbit Blog

The pharmacovigilance industry is locked in a race toward ever-more complicated signal detection algorithms. Cutting-edge technology like artificial intelligence, machine learning, and Big Data analytics is top-of-mind. While data science dominates the conversation, safety teams often overlook methods to optimize their approach to detection that do not require expensive data innovation programs. In this article,

So you found a potential safety signal in Eudravigilance EVDAS… now what? The EMA introduced and made available (to MAH’s and national competent authorities) the Eudravigilance Data Analysis System (EVDAS). This is great for companies and agencies who need advanced signal detection for post market surveillance. Included in EVDAS are tools to review case counts