Regulatory & Budget
Our Regulatory and Budget team specializes in preparing and negotiating budgets for industry sponsored clinical trials. We estimate coordinator and PI time, plus obtain price quotes for pharmacy and hospital services. Our process involves the entire study team (PI, department business manager, and coordinators), all of whom are welcome to offer comments and suggestions to make sure we have not missed anything, nor have under-budgeted for a complication procedure or assessment.
Once we have a consensus that the budget is approved, we prepare our budget for the sponsor, and negotiations begin. Once we come to an agreement with the sponsor, and the contract is fully executed, we will share our price quotes with the study team so that they know what to expect when the bills begin coming in for study expenses. If they find that the estimate is not covering the cost, we can initiate an amendment with the sponsor to rectify the problem.
We also have regulatory coordinators (who were once study coordinators) that can handle the IRB application process as well as preparing the regulatory documents. They understand that sponsors need these documents as soon as possible and have a process in place to take care of everything in an organized and efficient manner. Providing this service for your studies can free-up time for the coordinator to prepare for subject screening and recruitment.
Another part of this service includes processing protocol amendments through the IRB, revising consents forms, and preparing the IRB continuing review application. In other words, all of the administrative tasks for study start-up and the ongoing regulatory study management can be done for your study by an experienced team. Fees for all of these services are included as part of the Study budget.
For PI-initiated studies, we provide a consultation service to prompt new investigators to think about protocol development. We discuss the patient visit schedule, patient safety, and how to develop a strong protocol. We also can assist with an IND/IDE application is needed.
Budget & Regulatory services are available for PI initiated studies, as well as grant or other non-for-profit funded studies. The pricing structure changes, but the process does not.
For more information
Phyllis Klein, RN, BSN, CCRC
Director, Regulatory Compliance & Support