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Effective Management of Clinical Trials Budgets: A Detailed Guide for Industry-Sponsored Studies

This comprehensive guide outlines step-by-step procedures for managing industry-sponsored clinical trials budgets, including gathering sponsor information, protocol review, negotiation tips, and budget preparation. Learn how to navigate interactions with patients, ancillary services, and sponsor requirements effectively.

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Effective Management of Clinical Trials Budgets: A Detailed Guide for Industry-Sponsored Studies

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  1. ICTS Luncheon Clinical Trials – Industry Sponsored Budgets Ashley Tydon Stern Center Business Manager Chao Family Comprehensive Cancer Center

  2. Step by Step • Gather information from the sponsor • Protocol, IB • All manuals (Lab, Pharmacy, Imaging, Coordinator) • Central vendor questionnaires • Budget/Contract • FDA IND Acknowledgement

  3. Step by Step • High-Level Protocol Review • Use an Oncore Task List as a guide • Are there any interactions with a patient that will generate a charge in the hospital billing system? • Who is providing the drug/device? • What ancillary services will I need to use? • How many patients do we plan to enroll? • How long do we expect the study to be open to accrual and overall?

  4. Step by Step • Collect Research Rates/Quotes • Request a calendar/MCA if necessary (this will generate all the hospital based research rates) • Requests reviews and quotes from all the applicable ancillary services (IDS, Radiology, Pathology, ICTS) • Sort out operational/logistical questions with your PI and CRC to determine the plan for who does what when

  5. Build your internal budget • Internal Budget identifies study costs based on labor costs and research rates for procedures.

  6. Negotiate your sponsor’s external budget • External budgets are negotiated with Industry Sponsors based on the Fair Market Value • The external budget must cover all the costs included in the internal budget. Leave yourself room to negotiate • Formats for sponsor budgets vary, as each sponsor requires their own format • The bottom line here is most important – don’t be afraid to get creative.

  7. Helpful Hints • Don’t forget about the payment terms! • Standardize your start-up and administrative fees to avoid haggling on big ticket admin items • Know your audience and be service-orientated • A word about fee for service (fixed price contract) agreements • Don’t take their first offer – sponsors expect you to negotiate • The power of the PI

  8. Questions?

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