Financial concepts to conducting and managing clinical trials within budget

Escalating costs of clinical trials require pharmaceutical and biotechnology companies and contract research organizations (CRO) to control the cost of conducting and managing clinical trials. Along with reengineering and improvement programs aimed at cutting costs, appropriate development and management of study budget can contribute to ensuring the conduct of a study on time and within budget without sacrificing effectiveness and quality of data generated from the trials. Planning and developing an effective study budget requires a thorough analysis of the scope of work and tasks, activity timelines, labor and other resources required to complete the work, and assignment of realistic monetary values to the required resources. Also, during this preliminary stage, risk factors are identified and their impact on the proposed budget is analyzed, and resolutions, plans, and controls are instituted. The preliminary budget is then presented to financial stakeholders to ensure that the budget aligns with both short-term and long-term operational philosophy of the sponsors. During the operational phase of the clinical trials, the budget is monitored for adherence, and the required changes are made. Finally, a poststudy analysis measurement of the effectiveness of the study budget to completed work and any deviations are noted. A thorough understanding and application of budgetary development, management, and control processes increases the likelihood of enhancing overall financial efficiency and effectiveness of clinical trials, focusing study resources, fulfilling study goals, and completing the study within the targeted budget.