Signal Management

Signal management is a pivotal process for the proactive and timely identification of potential new safety risks for medicinal products. It is crucial to manage safety issues as they affect the risk-benefit balance of the product, patients and authorities need to be informed of the updates by labels and other means. We use robust methodologies for proper signal identification and documentation.

Signal Management Services

Signal management traverses the whole drug development cycle from clinical development to postmarketing. We help you identify, prioritize, validate and assess the signals. We perform signal management using a wide range of sources, e.g., spontaneous cases, safety data from clinical trials, and non-interventional studies and literature reports.

We ensure that Marketing Authorization Holders (MAHs) comply with their obligations for signal detection and management and us being fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality helps us achieve that.​