Early signal detection for effective risk management
Early detection of Adverse Events
Identification of risk factors and of population at risk
Systematic evaluation of relations between Adverse Events and products or drug interactions
Multi-objective design and robustness improvement of Risk Minimization Action Plans
Exhaustive analysis and hypotheses generation for End-of-Study and Periodic Safety Reports
Bias characterization in Pharmacovigilance databases
Design of new Composite Endpoints for Efficacy/Safety
How does KEM® bring added value to Safety Strategies?
KEM® provides an exhaustive hypotheses generation platform.
Unbiased logic based evaluation of relations between Adverse Events and products leads to key drivers for Safety Reports, Safety Specifications and Risk Minimization Action Plans.
By detecting weak signals (i.e. early Adverse Events) before they can be identified by traditional methods.
By finding novel relations between Structure, In Vitro and In Vivo data: Prevention of development failure through early detection of safety issues.
