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Challange
A global sponsor urgently required 450 packs of Abraxane (nab-paclitaxel) for multiple European sites after the original supplier fell short. The request came with tight lead times, limited local availability, and strict quality/regulatory constraints: a single-batch requirement for consistency and a Certificate of Analysis (CoA) for release. Any delay risked site activation and FPFV slippage across the study.

Solution
CSI mobilised a rapid, end-to-end contingency plan to secure and deliver compliant supply inside 72 hours:
Direct sourcing & batch lock: Leveraged manufacturer relationships to confirm one compliant batch and the full 450-pack quantity.
Regulatory & QP coordination: Prepared the necessary documentation and coordinated QP release to meet EU requirements and maintain audit readiness.
Cold-chain logistics: Arranged temperature-controlled transport to European depots with tight hand-offs to keep timelines intact.
Cross-site alignment: Sequenced shipments for rapid allocation across sites so activation could proceed without stock-related holds.
Operational transparency: Provided clear status updates and documentation packs to the sponsor and CRO to accelerate local approvals and depot receipt.
Issue escalation path: Stood up a 24/7 contact for customs or lane disruptions, with predefined alternates to avoid last-mile delays.

Result
CSI delivered the full 450 packs ahead of the internal deadline, preserving FPFV and preventing activation delays. The sponsor highlighted CSI’s speed, transparency, and compliance discipline—achieving 100% batch consistency with CoA provided and uninterrupted dosing at sites.

Case Study
CSI's 72-hour Abraxane Rescue Mission
From supply shortfall to on-time first-patient-first-visit across Europe, delivered in three days.
Challange
Sponsor needed 450 packs of Abraxane across multiple EU sites on an urgent timeline, requiring one batch with CoA—risking delays to FPFV.
Solution
CSI activated contingency sourcing, secured a single batch, completed regulatory/QP steps, and arranged temperature-controlled distribution—within 72 hours.
Result
Full quantity delivered ahead of the study timeline; no site activation delays; dosing stayed on track
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