Title : Signal identification

Client Situation

Based on certain feedback received from the QP PV on an immunosuppressive agent about a few defined risks, a mid-sized pharmaceutical company decided to put in place a formal process for safety monitoring and signal identification. This had to include review of case listings classified using the MedDRA hierarchy, review of literature to identify unexpected events that may be rare adverse reactions, identification of cases requiring additional review or analysis and an appropriate method for evaluation of a case series.