Effective Global Site Budgeting and Cost Management - Natalie Gosciminski
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The document discusses Johnson & Johnson's current process for global site budgeting and cost management for clinical trials. The current process aims to provide consistency in approach, fair reimbursement, transparency, and appropriate support for negotiators. It involves developing a global reimbursement range based on fair market value assumptions, collecting county-level cost data, and negotiating site budgets while documenting any exceptions. Challenges include accounting for complex trial procedures, making efficient yet globally comparable budget comparisons, and balancing timelines.
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Effective global site budgeting and cost management requires balancing sponsor expectations with site needs while navigating internal constraints. The document discusses opportunities to improve budgeting at both the sponsor and site level. For sponsors, it recommends providing high-level cost estimates pre-award and more detailed estimates post-award, while leveraging experience and consistency across countries. For sites, it suggests negotiating at a high level to avoid haggling over line items, and ensuring agreed budgets can be tracked and paid.
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The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research methods.
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The document discusses several topics related to clinical drug trials including:
1) Payment levels do not improve study performance but may raise questions for regulators, and certain CROs and sites get paid more for reasons other than performance.
2) A study is examining factors associated with faster completion times in clinical trials such as the nature of the organization running the study, study design, and site selection.
3) There is no difference in completion times between studies run by sponsor companies or CROs, but larger companies tend to be slower and pay more except in Latin America.
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