Clinical Trial Logistics

Clinical Supply Chain Planning
& Execution for CGT

1st FDA APPROVED CANCER VACCINE
PREFERRED LOGISTICS PARTNER

Having designed and implemented the clinical supply chains for the first FDA-approved cancer vaccine and the first two FDA-approved CAR-T therapies, QuickSTAT’s dedicated cell and gene therapy (CGT) experts are uniquely qualified to help design global supply chain models to your specific requirements. By leveraging our in-depth experience from the start, we can also help recommend packaging and provide regulatory guidance to streamline import and export processes. The end result is that your autologous or allogeneic therapy reaches every milestone on time and within temperature, with chain of custody and identity maintained throughout transit. Plus, with our advanced logistics platform – QuickOnline – you’ll be ready to scale quickly and easily when you’re ready to move to commercialization.

  • Expert temperature-controlled logistics for all temperature ranges to meet the critical transit times to ensure the viability of CGT therapies
  • Reusable shipper inventory management system including download and transmission of data from the logger
  • End-to-end VIP temperature-controlled packaging and management via our network of strategically located and GDP qualified conditioning facilities for accelerated
    turnaround
  • Robust chain of custody ensuring unmatched transparency of each apheresis, cell, gene, CAR-T or other personalized therapy shipment
  • Chain of identity management via QuickSTAT’s proprietary IT system, QuickOnline
  • In-transit storage (cold room) using GDP principles and best practices as well as access to temperature-controlled vehicles
  • Pre-qualified routing and real-time GPS tracking with automated alerts to avoid potential delays
  • A market-leading online IT platform, QuickOnline, that is easily integrated with orchestration platforms for real-time data such as temperature, location, orientation and light status
  • Detailed route planning ensuring primary, secondary, tertiary and quaternary routing options have been planned in advance for every contingency
Direct-To-Patient Solutions
Case Study

Direct-To-Patient Solutions
for a Rare Disease
Clinical Study

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