FMD K&L provides end-to-end solutions for your risk management and signal detection requirements
Our safety professionals offer a unique blend of knowledge regarding pharmacovigilance business processes, emerging regulatory requirements, and cutting-edge technology.
We work with our clients to define a proactive risk management strategy and robust business process to execute that strategy. The IT portion of our strategy incorporates the current state-of-the-art in data mining, analysis, and information delivery.
To ensure accurate assessment of safety signals, FMD K&L provides detection and analysis throughout the signal’s lifecycle, and makes prompt recommendations on findings and need for additional analyses.
|Level 1||Level 2||Level 3|
|Routinely identify, prioritize, analyze & report signals||Proactive signal detection & data mining (on demand)||Plan for strategic risk management|
|Medical professional analyzes individual case safety reports (ICSRs) daily||Statistics on disproportionality analysis based on external passive reporting databases, such as AERS and WHO Vigibase||Develop risk management and communication plans|
|Tracking and trending of safety signals over risk- and client-defined intervals||Access to FMD K&L subject matter experts||Develop risk minimization action plans|
|Produce formal analysis reports||Meet internally about emerging potential signals from aggregate analysis. Qualify and quantify data. Review safety data reports|