CBI's 2nd Annual Forum on: Maximize Investigator - Initiated Studies

March 28, 2006

Doubletree Hotel Philadelphia, Philadelphia PA

Understand the Legalities of the Investigator/Pharmaceutical Company Relationship During the IIS Process

Michelle Wilcox DeBarge, Partner, Wiggin and Dana LLP

Investigator-initiated studies raise a variety of issues concerning the investigator's legal obligations and the pharmaceutical company's role and responsibilities concerning compliance. This presentation addresses the legal responsibilities of investigators and explores the legal issues arising from the pharmaceutical company in an investigator-initiated study.

  • Identify and discuss potential legal issues arising from the study and in overseeing how the study is reviewed and conducted
  • Explore key legal concerns in investigator-initiated research and discuss some strategies for approaching them successfully
  • Manage risks contractually and through internal policies and procedures
  • Discuss solicitations and interaction with investigators
  • Exercising due diligence