Budget Management for Clinical Trials
Agenda
What does a clinical trial budget include?-
Feasibility
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Investigator fees
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CRO Costs
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Third Party Vendors e.g. Central Labs, IVRS, Couriers etc.
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Internal Pharma costs
The feasibility process and its impact on the cost
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The cost of Risk management!
How to Effectively Construct and Use Bid Grids
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Reduce confusion between suppliers and purchasers
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Define clear expectation for negotiations and costs
Investigator costs
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Developing an Investigator budget
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Costs of procedures
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Institutional overhead
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Pharmacy costs
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Ethics committee fees
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Setup costs
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Patient expenses – Ethics Committee considerations
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Payment schedules
CRO costs
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CRO pricing models
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CRO contracts and payment schedules
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Tracking project progress (Earned Value Analysis) (EVA)
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Accruals
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Pass through costs e.g. CRA travel and accommodation
Third party vendors
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Examples of budgets
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Tracking costs (EVA)
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Contracts
Internal pharma costs
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FTE requirements and Models – how much internal resource do you require to manage a CRO
Budget negotiation
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WIN-WIN negotiations - a role play exercise
Group discussion
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This part of the course will tackle the most common challenges faced when developing a budget management plan. If you have any specific issues you would like to discuss, please email coursemanager@pti-international.com in advance.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.