A pharmaceutical client sought to bring a new product to market in both the EU and the US. To support regulatory approval and market entry for a new diabetes therapy, they needed to conduct a comparative study between their product and existing market alternatives from both regions. The three-period, three-treatment, six-sequence phase 1 study required sourcing, labelling and distributing the two comparator materials and the new drug materials to the clinical trial site. ICON’s Accelerated Pharmaceutical Solutions (APS) team used its network and expertise to ensure the materials were secured and shipped in a timely manner to support the sponsor’s accelerated schedule goals. 

The primary challenge was coordinating the procurement and logistics of mid-volume pharmaceutical materials from both the US and EU. The study required an amount of material that was too large for wholesale resourcing, but not large enough to be a priority for the seller’s direct procurement processes. Our APS team leveraged ICON’s US Lenexa facility to expedite sourcing before onwards delivery to the EU site for central labelling of all three materials. To mitigate shipment challenges and costs, ICON labelled all materials in one campaign before onwards distribution to the clinical site and analytical labs in the US and China.

Additional challenges included:

• Management of complex international shipping and customs
• Timely labelling and delivery to clinical sites
• Working within a tight and shifting timeline, initially requiring rapid turnaround, then adjusting to a postponed study start
• Ensuring product stability despite delays

Our APS team proactively collected information to create a clear overview of supply requirements and shipping and labelling timelines. We executed a streamlined process supported by proactive communication and detailed coordination across procurement, logistics, and clinical functions to adapt to evolving timelines. 

Key actions included:

• Early preparation efforts and planned buffer times mitigating risks of procurement delays
• Procurement of all three drug materials in sufficient quantities, on time
• Shipping of all materials to ICON’s central pharmacy facility in Groningen for study specific labelling
• Labelling in bulk (not by study period), simplifying logistics
• Distribution of labelled materials to one clinical site and two supporting locations

Thanks to ICON’s experience, cross-functional coordination and deep network of connections, all materials were delivered on time and in full, well ahead of the revised study start date. Proactive planning and efficient execution coupled with a flexible, responsive approach to multi-region sourcing, procurement, labelling and distribution of three drug materials drove success amid the high logistical demands to support this global phase 1 clinical study.