Signal Detection & Management

FMD K&L provides end-to-end solutions for your risk management and signal detection requirements
Safety & Risk Management: Signal Detection and Management

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.

FMD K&L’s signal detection program is available in 3 levels, as shown below. Level 1 provides the most thorough level of service. Level 2 provides a similar level of service, with most services performed on demand. Level 3 consists of risk management and communication plans. Select the level that best suits your requirements:
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