Institute for International Research

In today’s environment, the amount paid to clinical investigators to conduct clinical trials is under increased scrutiny. In addition, questions about the standard of care that should be covered by health care companies to participants in clinical trials are among the most debated issues among international research ethics. To further complicate this landscape, care must be exercised to ensure that procedures conducted in clinical trials are not paid for by both the sponsoring pharmaceutical companies and the insurances of the participants involved in the trials. In this workshop, our leaders will discuss:

• What is Standard of Care?
• Differences between Usual and Customary care vs. research costs
• What can companies do to ensure clinical procedures are not doubled paid?

Special interactive exercises:

• Identify which clinical procedures are Standard of Care
• Work through a mock protocol to determine which procedures will be reimbursed by the sponsoring company and which will fall within Standard of Care
• Negotiate which clinical procedures are Standard of Care.

Holly Squires, Senior Vice President, TTC, LLC

Jim Laughlin, Vice President, TTC, LLC