A pharmaceutical client aimed to launch a new diabetes therapy in both the EU and US markets. To support regulatory approval and market entry, they needed to conduct a comparative study evaluating their product against existing alternatives from each region. The study—a three-period, three-treatment, six-sequence phase 1 trial—required sourcing, labelling, and distributing both comparator drugs and the investigational product to the clinical site. ICON’s Accelerated Pharmaceutical Solutions (APS) team leveraged its global network and deep expertise to secure and deliver all materials efficiently, aligning with the sponsor’s ambitious timeline and supporting their accelerated development 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

The 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.