Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?

The obvious win-win for a budget negotiation is a sponsor who gets good, clean data and meets their timelines, and a site that covers all their costs and makes a profit. It is common for sponsors who outsource clinical trial management to a CRO to also request support for site contract and budget negotiations. These sponsors may have an overall budget for their clinical trial, however, they often defer site cost assessment as part of CRO consulting. This content will highlight clinical trial site budgeting as both a risk mitigation strategy and an approach for sponsor to standardize site costs for optimal study budget management.

Clinical trial sites might include coverage analysis as part of their due diligence in reviewing sponsor budgets. They might also flow the cost of this work to the sponsor and when multiples sites do so, sponsors may incur additional costs for work that is replicate and redundant. Sponsors who understand clinical trials cost and coverage will see value in “owning” this work product for risk mitigation, efficient site budget negotiations and “best estimate” study cost forecasting.

Agenda Topics Include:

-Site Budgets for Risk Mitigation

• False claims
• Antikickback risks

-Site Budgets Based on Coverage Analysis

• Differentiate routine care from activities required solely for research
• Advantages of standardized site budgets

-Case Examples

• Coverage Analysis “discovery” and impact on clinical trial budget
• “Value Add” outcomes associated with cost and coverage analysis and standardized site budgets

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