More case studies
Challange
A global Phase III study required semaglutide (GLP-1 RA) as a comparator across North America, Europe, and APAC. The team faced high market demand and tight manufacturer allocations, region-by-region regulatory complexity (import/export rules and documentation), single-batch or batch-consistency expectations, CoA availability, shelf-life considerations, and temperature-controlled handling—any of which could slow site supply or fragment quality across regions.
Solution
CSI executed a structured, multi-region program:
Direct manufacturer access: Secured volume with batch consistency across sites and regions, aligning expiry and presentation to protocol needs.
Regulatory & QA ownership: Managed import/export paperwork, obtained region-specific approvals, and supplied CoAs for every batch, synchronising with country-level submission calendars to eliminate idle time at depots.
Global cold-chain logistics: Planned temperature-controlled shipments with end-to-end tracking to depots and sites, optimising lane selection, packaging, and hand-over points to protect stability.
Risk mitigation: Implemented backup supply, secondary lanes, and contingency routing to avoid stockouts or customs-related delays; pre-cleared documentation packets to shorten border dwell times.
Inventory planning: Set site-level par levels and replenishment triggers, with proactive resupply windows to cover screen-fail variability and recruitment surges.
Governance & communication: Ran a weekly cadence with sponsor/CRO and provided shipment dashboards, exception logs, and audit-ready documentation packs.
Result
All global sites received compliant semaglutide on schedule, enabling the study to progress without supply interruptions. The approach reduced lead times, ensured consistent, high-quality comparators across regions, and lowered sourcing risk for the sponsor through proactive regulatory, logistics, and quality controls.
Case Study
Effective Sourcing of Semaglutide for a Global Phase III Clinical Trial
Ensuring batch-consistent, compliant comparator supply across NA, EU, and APAC - on time and uninterrupted.
Challange
Global Phase III trial needed semaglutide comparators across multiple regions, with single-batch consistency, CoAs, and strict regulatory compliance.
Solution
CSI used direct manufacturer access, managed region-specific approvals and CoAs, and ran temperature-controlled, tracked logistics with contingency supply.
Result
Comparator delivered to all sites; reduced lead times, consistent quality, and no supply interruptions to the study.
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