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 Manufacturing & Pharmacy Services 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 quantities that were too large for wholesale resourcing, yet not large enough to be prioritised through the sellers’ standard procurement channels. ICON leveraged its Lenexa facility in the US to accelerate material sourcing, then coordinated onward delivery to an EU site for centralised labelling of all three materials. To minimise shipment complexities and associated costs, a single labelling campaign was conducted prior to onward distribution to the clinical site and analytical laboratories 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

ICON proactively gathered key information to develop a clear overview of supply requirements, as well as shipping and labelling timelines. A streamlined approach was implemented, supported by proactive communication and close coordination across procurement, logistics, and clinical functions, enabling the team to effectively 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.