Expertise We Offer
Clinical Supplies Management
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Project Management
We understand the value of timelines and virtually embed our clinical supply chain experts to help you meet your milestones.
IIR/IIS
Manage your internal and external (IIR/IIS) clinical supplies
IRT
Prepare specs, execute the UAT and monitor the system
Inventory Management
Ensure that sites and depots have correct inventory
Forecasting
Formulate distribution and resupply strategies
Reverse Reconciliation
Manage end of study activities
Import / Export
Expertise to move your drug around the globe. Regulation and trade compliance expertise.
Collaboration
Work with your systems, SOPs, and vendors
Vendor Management
Expertise to connect you to a network of experienced clinical supply chain vendors for manufacturing, packaging, comparator, labeling, distribution, and destruction for Phases I - IV clinical trials.
Clinical Supplies Preparation
Oversee and advocate the clinical supplies process for our customer
Supply Chain Partners
Assist with the selection of optimal supply partners
Planning and Collaboration
Work with our customer's internal and external partners in order to meet milestones
Crisis Management
Crisis Management
Rapid deployment of our contingent workforce to prevent or resolve urgent compliance and regulatory issues
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Catastrophic Events
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Critical Staffing Needs
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FDA and Regulatory Inspections
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IP Shortage
Consulting
Providing expertise to you and your team in order to better plan, prepare, and manage your study.
Compliance
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CFR
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FDA Inspection
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GxP Processes
Process
Advocacy and oversight of the development of investigational materials from manufacture through global distribution of clinical supplies to Phase I-IV
Forecasting
Manage studies of any complexity as well as any potential changes and threats
Training
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Orientation and on-boarding
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Workforce coaching
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Study initiation presentations
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