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Case Study: Patient-Centric IRT Management for Compassionate Use Studies

Speakers: Brett Castano, Sr. Architect Project Management, endpoint and Craig Duffy, Senior Manager Investigational Supply Chain Manager, Blueprint Medicines

Speakers: Brett Castano, Sr. Architect Project Management, endpoint and Craig Duffy, Senior Manager Investigational Supply Chain Manager, Blueprint Medicines

When developing lifesaving medications for patients is at your core, it is essential to streamline the processes of managing the critical clinical supplies trial data through advanced technology. The pooled clinical supply approach, when coupled with a comprehensive control system, offers unique strategic advantages for efficiency and data integrity. This ensures the data being submitted for drug approval is of highest quality to help expedite the process and get the novel medications in the hands of patients who need them most.

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What you’ll learn

  • A sponsor’s view:
    • Challenges faced to synchronize and harmonize their pooled supply approach
    • Efficiencies of an overarching platform to manage pooled supply for both traditional IRT and IIT/Phase 1 studies to reduce manual oversight
  • Insight into implementing this approach and lessons learned
  • Ways to create other efficiencies in the future through advanced eClinical technology

Who should attend

Individuals working within sponsor companies in roles related to clinical trial management, including:

  • Head of Clinical Operations
  • Clinical Operations Group (Director, Sr. Study Manager, etc.)
  • Outsourcing Department/Vendor Management
  • Director or Manager of Clinical Supply Chain
  • Data Managers
  • IRT Specialists

Speakers

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