Risk Management & Signaling Implementation

15 December 2014 By

December 2014.  Foresight was engaged by a midsized pharmaceutical company to design and implement Risk Management and Signaling Solutions in two phases (Phase I & Phase II). 

Foresight performed the following services in Phase I on behalf of the customer:
  • Guide and assist the customer in the development of a comprehensive Safety Evaluation and Tier Change Process including:
    • Refinement and Detailing of the Safety Evaluation Process in an onsite workshop
    • Development of the Evaluation Documents to be used both in the paper and electronic process
    • Refinement and Detailing of the Tier Change Process in an onsite workshop
    • Development of the Tier Change Documents to be used both in the paper and electronic process
  • Development of SOPs with client input
    • Reviewing and managing Clinical Study Safety Data for Safety Signals
    • Periodic Safety Analysis of Marketed Products
    • Safety Signal Analysis for Products
    • Preparation and Submission of PADERs to the FDA
    • Guide and assist in the development of the User and Functional Requirements for an Electronic Workflow Solution supporting the Safety Evaluation and Tier Change Process
Foresight performed the following services in Phase II on behalf of the customer:
  • Assist in the implementation of the Electronic Workflow Solution
  • Guide and assist in the development of the User and Functional Requirements for a Signaling Solution