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Pharmacovigilance Outsourcing

Outsourcing your Pharmacovigilance activities to a Drug Safety Specialist

Pharmacovigilance outsourcing

Trends in outsourcing

The trend for the outsourcing of pharmacovigilance activities to drug safety specialists is gaining momentum as companies both large and small are looking for ways to reduce costs in some areas in order to maximise the resources available for R & D. Pharmacovigilance activities are process driven making them ideal candidates for outsourcing.

A study of pharmacovigilance deployments has shown that substantial cost savings of 30-40% can be made by outsourcing pharmacovigilance

Ref: 'Pharmacovigilance in the New Pharma' Ron Fitzmartin and John Wise Touch Briefings 2010

It is estimated that more than 80% of pharmaceutical companies outsource at least one pharmacovigilance activity. The activity most likely to be placed in the hands of a pharmacovigilance consultancy is that of spontaneous case handling.

Main Reasons to outsource your pharmacovigilance function

  • Costs savings - on high fixed costs of in-house resources
  • Stability - your service provider will be a 'constant' in the fast moving PV paradigm
    • No need to worry about your QPPv leaving - causing expensive variations
  • Lack of expertise in house
  • The need for temporary extra cover
  • Inspection cover –Save valuable resources
  • 27/7 365 Days Pharmacovigilance hotline for spontaneous cases

Who would you consider outsourcing to:

There are 3 main types of companies offering pharmacovigilance services

  • CROs historically have taken on the PV role during the running of clinical trials
  • More recently BPOs (Business Process Outsourcing organisations - their roots being in IT) have stepped in, in response to the increase in demand for post authorisation PV services
  • Specialist pharmacovigilance consultancies, such as CambReg

All 3 types will offer a full suite of high quality pharmacovigilance services, however for CROs and BPOs PV is not the main part of their business and therefore you are less likely to receive the tailored and personal service that you will receive from a specialist drug safety monitoring consultancy like ours.

Each new client we take on is looking to forge a trustworthy and long lived partnership