Advanced Signal Management

PrimeVigilance has industry experience in creating efficient, compliant, multidisciplinary processes for signal detection and management, including the appropriate use of up to date statistical methodologies and data mining approaches within product safety risk management systems.

PrimeVigilance is well versed in the interpretation of outputs from automated data mining analyses. PrimeVigilance’s analyses experts have been involved hands-on in discussions with the EMA EV-WG and in developing solutions following the new sponsor obligations for signal management based on GVP Module IX updates.