Five Tips for Creating & Negotiating the Best Clinical Trial Budget for Your Site

Are you looking at trial budgeting through a real-world lens? Ideally, you receive the sponsor's budget table, and your site has a standard cost for every protocol item. You send your site's cost request to the sponsor to initiate negotiations, and the sponsor accepts all budget requests within 30 days. 
 
In reality, most sites see at least one round of negotiation involving phone calls, clarification emails and justification requests. Prolonged negotiations can lead to study delays. How can you streamline the process? Following are our top five tips.
 
1. Standard Fee Schedules - Have a general budgeting process for all studies to ensure budget quality and have cost documentation available before negotiations. Standard items include: 
  • Time and effort  
    • Hourly rates for study staff budgeting
    • Baseline time estimates for common activities
  • Patient care costs
    • Chargemaster/s – single, research-specific or multiple
    • Clear Medicare pricing documentation 
    • Contractor rates for routine outside services 
    • Bottom-line and negotiation thresholds for items in fee schedule
  • Administrative fees
    • Standard fee schedule per department 
    • Study-level internal site fees 
    • Non-negotiable fees
2. Study-Specific Considerations - Before building the budget, have a defined process, including:
  • Coverage analysis, if required
  • Details from coverage analyst 
  • Notes from study team with special requirements 
  • Departmental protocol reviews
  • Mirror recently negotiated budget
  • Confirmation of budget contacts 
3. Internal Budget Development - Each site's internal budget development process may look slightly different, but these tactics can pay off:
 
 
Work with the study team to identify activities with special timing or staffing requirements. They should confirm requirements for activity, including heavy visits, such as extended PK sampling days, observation days or protocols requiring inpatient stays. Also include data management costs and ensure that you have appropriate PI and coordinator time allocated. 
 
4. Negotiations - Ensure clear expectations for the process with these steps:
  • Include an ideal timeline for completion. 
  • Create site standards for follow-up timelines.
  • Be prepared for a counteroffer below your bottom line. 
Prepare FAQs for overhead, fair market value, IRB fees and start-up costs. Having documentation of start-up costs will help fast-track the process. Negotiate for start-up payments to be made automatically upon execution to save administrative time and effort. 
 
5. Amendments & Cancellations - Understand your site's process and standards for these negotiation situations:
 
 
 
Conclusion
Preparing for budget challenges avoids delays and leads to smoother negotiations. Reaching an ideal but realistic budget quickly allows you to get patients the treatment they need. Learn more with WCG’s Managed Research Solutions. 
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