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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

Project M
Vendor M

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 

  • Catastrophic Events 

  • Critical Staffing Needs

  • FDA and Regulatory Inspections

  • IP Shortage 

Crisis M

Consulting

Providing expertise to you and your team in order to better plan, prepare, and manage your study.

Compliance

  • CFR

  • FDA Inspection

  • 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

  • Orientation and on-boarding 

  • Workforce coaching

  • Study initiation presentations

Consulting
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