Signal Detection and Risk Management

Foresight Group provides an end-to-end solution for risk management and signal detection. Our consultants are experts in pharmacovigilance business processes, regulatory requirements, and safety technology. We tap into this expertise to define a proactive risk management strategy for our clients. We ensure that the most fitting technology solution is selected to meet the business needs, whether it is an off-the-shelf quantitative signal detection system or a customized product.We then help our clients implement the solution.To this end, we examine their product portfolio using a risk-based approach to define a proactive strategy that focuses on potentially problematic issues.This enables our clients to allocate resources more efficiently.Based on the strategy, we help define a structured and systematic business process supported by a validated technology solution.The abundance of data typically associated with statistical signaling solutions has the potential to mix information about genuine issues with that of unworthy findings (noise). This in turn could divert your resources from detecting and repairing serious problems.Thus, Foresight employs a methodology that mitigates the risk of data dredging.

Our approach typically follows these segments of work:

Analysis and Design

  • Analyze product portfolio, as well as existing risk management and signal detection activities
  • Define future risk management strategy and signal detection process
  • Select technology solution

Business Process Implementation

  • Document future business process and workflow maps
  • Define documentation structure
  • Author or update policy documents and standard operating procedures
  • Support pilot planning and execution activities
  • Develop training materials and conduct training on the new process

Technology Solution Implementation

  • Author User and Functional Requirements
  • Create Configuration Specifications
  • Develop and execute qualification scripts
  • Develop training materials on technology solutions
  • Conduct training on technology solutions