Case Study: Comparator Sourcing of Semaglutide for a Global Phase III Study

Request: A global pharmaceutical sponsor conducting a Phase III clinical trial required Semaglutide, a GLP-1 receptor agonist, as a comparator drug. The study spanned multiple regions, including North America, Europe, and Asia-Pacific, necessitating a consistent and compliant supply of the drug across various regulatory landscapes. The sponsor needed a reliable partner to source Semaglutide efficiently while ensuring batch consistency, Certificates of Analysis (CoA) availability and regulatory compliance for each region.

Challenge: Sourcing Semaglutide for a global clinical trial presented several challenges:

• Limited Market Availability: Semaglutide is a high-demand medication with strict allocation policies from manufacturers.

• Regulatory Complexities: Different regulatory requirements across multiple countries, including import/export restrictions and regional documentation needs.

• Supply Constraints: Ensuring batch consistency across all study sites while navigating complex logistics and potential delays.

• Stringent Quality Standards: The need for CoAs, shelf-life requirements and temperature-controlled handling for the drug’s stability.

  
  

Solution: Clinical Services International (CSI) leveraged its expertise and manufacturer relationships to successfully source and deliver Semaglutide for the trial:

• Direct Sourcing: CSI’s established accounts with major pharmaceutical manufacturers allowed for a streamlined procurement process, securing Semaglutide with batch consistency across all sites.

• Regulatory and Quality Assurance: CSI ensured full regulatory compliance by managing import/export documentation, obtaining region-specific approvals and providing CoAs for each batch.

• Global Logistics Management: CSI’s supply chain expertise enabled temperature-controlled shipments with end-to-end tracking, ensuring on-time deliveries to study locations worldwide.

• Risk Mitigation Strategy: By implementing a proactive risk management plan, including backup supply strategies and contingency logistics, CSI minimized the risk of supply interruptions.

  
  

Outcome: CSI successfully delivered Semaglutide to all global sites, ensuring uninterrupted clinical trial progress. The pharmaceutical sponsor benefited from:

• Reduced lead times and regulatory delays.

• Consistent and high-quality supply of the comparator drug.

• Minimized risks associated with sourcing challenges.

By partnering with CSI, the sponsor ensured a seamless supply chain, enabling the Phase II study to progress on schedule while maintaining compliance across all regions.