Strategy Consulting & Study Design.

Preparing you to measure real-world outcomes, on a national and global scale.



  • Strategic Advice On Risk Management Planning

    • • What RM tool should we use?
    • Crafting your Global and National plans, e.g.: Should we add a Canadian component to the RMP?
    • Pre-approval Drug Utilization Studies

     

  • Preparation of Pre-Submission Meetings–

    • What are the safety issues (safety specifications)?
    • Is the risk potential or identified?

 

 

  • Risk Management Plan Drafting/Writing

–In accordance with Volume 9A

 

 






  • Effectiveness Of Risk Minimization Interventions
  • How to assess value differentiation for reimbursement purposes
  • Pharmacovigilance

    • • Concrete signal detection solutions for small- to medium-size companies
    • Safety analysis
    • Design & Implementation of Data-Mining SOPs