Clinical Supplies Management (CSM) brings the experience of our drug supply professionals to a client’s study, providing expertise throughout the complete clinical supply project lifecycle - from initial packaging strategy to final drug accountability.
Supported by forecasting and simulation capabilities, we can optimize study design and ensure cost-effective approaches for on-going clinical supply management for either single protocols or entire programs.
Benefits:
- Single point of contact coordinating the necessary information between clinical functions
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Ensures that clinical drugs and supplies are available in appropriate quantities where they are needed and when they are needed
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Supports cost saving through reducing drug wastage:
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unnecessary drug campaigns
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more efficient shipping and inventory practices
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optimized comparator procurement
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minimizes the risk of a subject not having drug available at their drug assignment visit.
Features:
- Creation of overall packaging and distribution plan/strategy
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Drug projections and enrollment projections
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Determine subject drug visit requirements
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Supports comparator procurement strategies
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Re-forecast ongoing supply requirements as study progresses
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Request manual drug orders
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Manage/monitor site/system drug orders and site drug shipments
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Manage/monitor site inventory levels
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Manage/monitor ancillary and comparator supplies inventory
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Support for IRT design/approval (URS/UAT)
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Assist in distribution pack out design
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Assist in coordination of temperature monitor processing
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Assist with creating shipment excursion release process
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Provide final drug accountability reports to Clinical
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Coordinate drug return and accountability process
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Coordinate destruction of reconciled study drug