Study Conduct: A Big Part of the Budget

The use of CROs to conduct clinical trials, including data management, has increased over the years and will most likely continue to represent a significant part of many companies' clinical research efforts. Consequently, sponsor companies need to be able to budget the costs of these outsourced studies as effectively as possible. No one is pleased when a sponsor company requests bids for a study, or asks a preferred provider to submit cost estimates and the lowest submitted figures are substantially above the amounts expected by the sponsor company.

During the budgeting process, a refined bid grid enables a company to establish both the overall outsourcing budget and the expected budget for individual outsourced studies.

Trial Budgets: Over 50 Sites vs. Under 50 Sites

The bid grid also enables companies working with preferred providers to forecast costs for individual projects more easily. Equally critical are the cost numbers that go into that bid grid.

For completely outsourced studies, study conduct represents the largest portion of the project, followed by project management and then data management. However, as the number of sites in a study increases so does the relative cost importance of project management and data management.—TTC (www.ttc-llc.com)