Protocol Cost Savings Analysis for Sponsors and CROs

Protocol Cost Savings Analysis (PCSA) is a comprehensive review of the clinical procedures in a protocol, focusing on determining billable items under the Medicare Clinical Trial Policy (National Coverage Determination 310.1). By conducting a PCSA, our clients are able to offset R&D expenses by aligning protocol procedures with routine care since these expenses are reimbursed by governmental (i.e., Medicare) or private third-party payors. 




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  • Participate in protocol development discussions to assist in aligning the study procedure schedule and objectives with routine care

  • Analyze draft protocol to determine if it is a qualifying clinical trial per Medicare guidelines and identify any additional cost savings

  • Develop study-specific inclusive, detailed activity grids and complete a coverage analysis of all procedures and tests outlined in the protocol by documenting routine care and research items using supporting Medicare rational for each determination

  • Review institution-specific justification of routine care to assist sponsor negotiations

  • Perform a thorough review of the clinical trial agreement, budget and sponsor informed consent documents to ensure synchronization and reduce the need for amendments




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Enhance Internal Operational Efficiencies Resulting in Cost Savings

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Support Routine Care Determinations with Medicare Guidelines

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Harmonize Key Study Documents to Reduce the Need for Amendments

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Accelerate Study Start-up Timelines due to Improved Processes