Budgeting for Industry
Sponsored Clinical Trials
David Cloutier
Director, Research Center Management and
Development
Objectives
• Describe costs associated with clinical trial
conduct
• Review a sample internal budget
• Identify hidden costs
• Identify the elements of sponsor budget
• Describe post award activities related to
payment and budget changes
Budget Prioritization
Prioritize budget analysis and feasibility
• Request a draft budget and protocol as soon
as you are approached for the trial
• The budget and contract can take as long to
negotiate as the Informed Consent Document
• You can make a draft budget while waiting on
the sponsor’s budget
Interest and feasibility
Study the protocol carefully
Is the project feasible for your site
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Academic / Scientific interest
Resources
Research staff
Patient population
Identify Your Costs
Review the Protocol Schematic and Informed
Consent Document
Review the Protocol Schematic
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Hospital procedures (technical fees)
Physician practice costs (professional fees)
Lab costs
How many visits / Length of study
Visits until randomization
Coordinator time per visit / post visit
Compare to visits and procedures listed in the informed
consent document
Build the Budget
• Per Patient Costs
• Study Level Costs
Per Patient Costs
• Breakdown procedures by Coordinator,
Physician, and Hospital Fees
– ECG cost / Pro Fees / Coordinator filing
– Lab tests / review / CRF filing
– ECHO cost / Pro Fees / CRF filing
– Medical History / CRF filing
– Dispensing fees
• Assign costs for coordinator / staff time
• Apply Indirect Cost rate
– 25% Industry Sponsored Trials
Coordinator Fees
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Regulatory document collection / filing
Correspondence filing
Case Report Form completion, submission
Scheduling for pt visits, tests/scans
Participant stipend processing
Data query resolution
Sponsor invoicing / accounts receivable
Study Level Costs
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Administrative Startup Fee
Pharmacy Set Up Fee
Document archiving, offsite storage
Advertising
Unscheduled visits
SAE reporting
Monitor visits
IRB Fees
– Initial Review, Amendments, Renewals
Startup Fee ($1500 - $5000)
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Protocol Review
Site Initiation Visit
Contract and Budget Review
Investigator Meeting
Regulatory Documentation filing
Initial IRB Application preparation / submission
Informed Consent Document
– IRB Requested Revisions
– Negotiating ICD w/ Sponsor
• Office Supplies
Hidden Costs
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Extended start-up activities / timeline
Pre-screening activities
Increased hospital procedure costs
Unscheduled visits
Tracking study accounts receivable
Query resolution
Amendments
The Sponsor Budget
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Per Patient Amount comparable?
Study Level costs covered?
Indirect cost rate correct?
Enrollment goals feasible?
Screen failure reimbursement acceptable?
Negotiating
• Internal budget will differ from sponsor offer
• Discourage sharing detailed internal budget with sponsor
• Your internal costs may limit negotiation of future
projects
• Sponsors retain database of previously negotiated
budgets
Negotiate reimbursement at the same level of detail as
sponsor template
– Per-visit reimbursements are acceptable
– Line item expenses are acceptable
Sponsor Payment Terms
• What is the payment schedule?
– Ad Hoc
– Quarterly
– After Monitor Visits and CRF auditing
• Are they relying on you to Invoice?
– For all payments
– Study Level Costs
– Per Visit
Track your payments
• Budget statement
• Payment memo
• Invoice for your “Study Level Costs” and
reimbursable expenses
• Sponsors miss payments
• Request periodic payment reports from sponsors to
ensure that EFTs were received and directed to the
correct fund-org
• Some sponsors rely on you to invoice for all the
visits.
Initial Payment
Initial payment may include pre-payment
 Untangle start-up fees from initial payment by negotiating a
“non-refundable” start-up fee
Re-Negotiation is an Option
• Review protocol amendments for new
work…
– If the amendment changes work load or adds
procedures: re-negotiate
– If sponsor allows more patients to be enrolled,
request more screen failures