Study Budgeting

Developing and Maintaining Sound Financial Plans

Our experienced financial professionals work closely with Principal Investigators and Study Teams to develop, negotiate, and maintain accurate clinical research budgets in accordance with Medicare and institutional policies that are sustainable throughout the lifecycle of the trial.

Pre-Award financial services include:

  • Perform Coverage Analysis** and Billing Grid production to ensure correct billing and Medicare coverage eligibility
  • Prepare financial analyses on device trials, as necessary, serving as a resource to investigators on device regulations and ensure receipt of proper device approvals
  • Perform Compliance Review to ensure alignment of Billing Grid, budget, ICF language and contract terms
  • Negotiate the sponsor budget in industry-sponsored clinical trials*
    • Review clinical research protocols to develop fiscally sound budgets*
    • Review sponsor budget documents and revise, as needed*
  • Distribute final compliance Summary Review to the Principal Investigator (PI) and Study Teams, IRB, and institutional governances*
  • Prepare final locked Billing Grid and request PI written approval and notify the Office of Sponsored Programs (OSP), as applicable
  • Perform Pre-Activation review for implementation
  • Activate the Billing Grid for implementation release in Epic
*   UW CTO Fee for service
** May be performed by third party vendor for a fee

Post-Award financial services include:

  • Reviewing Epic hospital and professional charges for patients enrolled in clinical trials
  • Leveraging the study team’s linking of the encounter and documentation of timepoints and billing grid
  • Routing charges appropriately to the study, or to the patient/insurance
  • Ensuring compliant coding of research-related patient claims to insurance
  • Ensuring alignment of charge routing between hospital charges and professional fees
  • Compliance with UW School of Medicine Clinical Research Effort policy when billing professional fees
  • Providing feedback to the coding team and CTMS office when Epic charges do not align with the billing grid
  • Invoicing study teams for Epic study-billable charges, and collecting payment
  • Managing the study activation workflow (push from OnCore to Epic)
  • Managing the billing grid activation/update workflow (push from OnCore to Epic)
  • Performing the study completion workflow in Epic
  • Ensuring quality control on the enrollment workflow
  • Coordinating workflow with Noridian after CMS approval is received for IDE devices