How to Use Outsourcing to Reduce Clinical Development Risk

May 28, 2015

Steve_Herbert_May_Outsourcing_blogRisks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.

There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25 billion dollars worth of clinical development projects. That is over a quarter of the $98 billion dollars currently devoted to clinical drug development.

This naturally raises several questions:

  • What are the risks of outsourcing?
  • Can outsourcing be used to reduce other forms of clinical development risks?
  • What is the best way to manage all of these risks.  

On May 19th, Cytel Senior Vice President Steve Herbert delivered a lecture on the idea of risk in clinical development outsourcing at the annual 5th Annual Outsourcing in Clinical Trials Conference in Dusseldorf, Germany . Click below to see the slides. You will learn:

  • A coherent way to categorize risk in the context of pharmaceutical development
  • How outsourcing can effect risk, cost and outcome in both good and bad ways
  • Why you need to pay closer attention to your biostats & data management provider
  • How to use outsourcing to reduce risk

Read Steve's Slides