Budgeting for Industry Sponsored Trials

Without a properly negotiated and prepared budget, you and the institution will lose money on a clinical trial. Because a clinical trial contract is a fixed-price agreement, you are obligated to perform the work described in the contract, even if your actual costs exceed the total contracted amount.

The sponsor may initially quote a budget amount allocated to each site or may ask you to develop a budget for their review. In the case of a sponsor-determined budget, the quoted amount may be adequate or generous, but this is often not the case.

In most cases, a reasonable compromise can be reached after performing cost analysis and reporting those calculated costs to the sponsor. However, on occasion, it may be necessary for you to turn down a clinical trial because of an inadequate budget offer.

The Research Billing Plan

In order to perform a cost analysis and to ensure that billing for your study participants happens correctly, a comprehensive billing plan must be documented.  

The research billing plan identifies all tests and services provided to study participants and provides detail on which should be paid for by your grant and which (if any) can be billed to 3rd party payers (i.e. Medicare).

The CTO will work with each PI and their study team, at the time of study cost analysis and budget development to create this billing plan.  

Contact the CTO (Alyssa Parks at 202-687-7565 or ajp279@georgetown.edu) for instructions and help with calculating research fees for trial-related tests and services.

Budget Negotiation with Sponsor

After performing a cost analysis of your new clinical trial and a review of the budget provided by the sponsor, the CTO handles sponsor negotiations concerning the study budget for you.