A clinical trial sponsor required a cost-effective and reliable sourcing strategy for a large-scale global study involving a high-cost, branded oncology product. The trial spanned multiple regions, with drug supply needed for sites across the United States, the European Union (EU), and the Asia-Pacific (APAC) region.

The Challenges

The sponsor’s initial request was to source the product domestically for US sites while seeking a strategic solution for all Rest of World (RoW) locations. However, this approach presented significant challenges:

• High Cost in the US – The price of the product was significantly higher in the US compared to other regions.
• Regulatory Barriers – Accessing the drug in the US required trial disclosure, which the sponsor sought to avoid.
• Unlicensed Territories – Some trial countries lacked local licensing for the drug, making local sourcing impossible.

Midwinter’s Strategic Solution

Midwinter conducted a comprehensive evaluation to identify an optimal sourcing strategy. Our approach centered on utilizing EU-sourced drug across all global trial sites, including the US.

Regulatory Compliance and Cost Efficiency

To gain FDA approval for using EU-sourced drug in the US, Midwinter provided essential documentation, including:

• Manufacturing site information
• Proof of authenticity
• Supporting documents to demonstrate equivalency in the manufacturing process

With this information, the FDA approved the use of the EU product, resulting in a 65% reduction in comparator drug spend for US trial sites and ensuring a consistent global supply.

Maintaining Trial Confidentiality

By leveraging the EU’s well-established wholesale distribution network, we eliminated the need to disclose trial details to the manufacturer – an essential requirement for obtaining the US product. This protected the sponsor’s confidentiality while securing a streamlined supply chain.

Seamless Import and Distribution

Midwinter ensured that delivering EU-sourced product to a US-based packaging site would be a smooth process. We advised the sponsor to avoid restricting the IND to US-sourced drug.

• Hassle-free customs processing with a clear justification for import
• Pre-clearance with customs authorities, avoiding delays
• Detailed documentation (HTS codes, regulatory compliance materials) for seamless shipment approvals

With our deep expertise in navigating global shipments, each delivery proceeded without issue.

Key Benefits of Midwinter’s Approach

Our strategy provided three major advantages:

1. Significant Cost Savings – A 65% reduction in US comparator drug spend.
2. Supply Chain Consistency – A single, global drug source ensured seamless distribution.
3. Confidentiality – No requirement to disclose trial details to the manufacturer.

Future-Proofing the Supply Chain

Midwinter advised the sponsor to retain alternative sourcing options as a contingency, including:

• US sourcing, if required, despite higher costs.
• Expanding to additional global regions as the drug gains broader regulatory approval.

With this strategic framework and contingency in place, the study continues successfully into its third year, benefiting from a predictable, cost-effective, and confidential supply chain.