The challenges that research sites face with respect to clinical trial budgeting is that they do not know how much the different activities cost or how to synthesize them into one overall budget plan. Additionally, a number of factors have contributed to the deceleration of grants ranging from sponsors funding fewer clinical trials, sponsors spending more on late-phase clinical trials overseas, to more complex protocols requiring smaller numbers of patients per investigative site and more difficult to administer. This session will focus solely on clinical trial budgeting at the site level. Exploration of the costs of personnel, recruitment, startup, close-out activities, monitoring, document storage, and more will be thoroughly examined and combined into one overall trial budget.

Learning Objectives:
Discuss the financial health and operations of the clinical research site in a competitive market and the changes needed in order to survive in the current economic climate
Be able to perform a thorough budget analysis for a clinical trial at a research site and evaluate costs properly for decision making
Describe the clinical trial budgeting process from one sponsor's perspective with a focus on fostering sponsor-site collaboration.