Global clinical trials require seamless coordination of supplies, documents, and materials across multiple countries and regulatory jurisdictions. Whilst the complexity of these operations has always been significant, 2025 has brought new challenges that are reshaping how US pharmaceutical companies and CROs approach international logistics.
Recent regulatory changes, evolving export requirements, and increased compliance demands are creating bottlenecks that can delay trials and increase costs. Understanding these challenges, and implementing effective solutions, has become critical for maintaining competitive trial timelines and budgets.
Major challenges facing clinical trial logistics in 2025
Export control complexities became a major burden for US pharmaceutical companies and CROs in 2025. The Export Administration Regulations (EAR) require extensive classification of exported materials, with many pharmaceutical and biotechnology products subject to licensing requirements. Electronic Export Information (EEI) must be filed through the Automated Export System (AESDirect) for most shipments valued over $2,500, requiring detailed product descriptions, proper commodity classifications, and end-user information.
US exporters face extensive screening requirements against OFAC, BIS, and State Department restricted party lists - obligations that are generally less complex for UK-based operations. Companies must verify that all parties involved in transactions, including trial sites, investigators, and logistics providers, do not appear on restricted party lists. This screening must be documented and maintained for compliance purposes.
Sanctions and compliance challenges created operational difficulties throughout the year. US companies must navigate sanctions that are usually more expansive compared to the EU, adding time and complexity to international shipments, particularly when dealing with multiple international trial sites.
Customs and regulatory complexity became increasingly problematic for companies relying solely on US-based operations. US Customs enforcement has become stricter with inspections and compliance requirements, whilst the domestic policy orientation prioritises national security considerations that can complicate commercial pharmaceutical exports.
How dual UK/US operations solve these problems
A dual-hub approach allows US pharmaceutical companies to optimise their clinical trial supply chain based on destination requirements. The UK's Trade and Cooperation Agreement with the EU provides tariff-free access for most goods meeting rules of origin requirements, simplifying shipments to European trial sites.
UK export control regulations are generally less complex than US EAR requirements for commercial pharmaceutical products. Fewer items require export licences, and the documentation requirements are typically more straightforward. This can significantly reduce processing time for international shipments.
Geographic proximity to European markets offers practical advantages. Shorter shipping distances mean faster transit times, reduced freight costs, and easier coordination of expedited shipments when needed. Road, rail, and ferry connections provide alternatives to air freight for non-urgent materials. Time zone alignment between the UK and European trial sites enables real-time communication and faster resolution of logistics issues. When documentation corrections or approvals are needed, UK-based operations can coordinate directly with European authorities during overlapping business hours.
US operations can handle domestic trials and shipments to the Americas, whilst UK operations manage European and other international destinations. This geographic specialisation can reduce compliance complexity and improve overall efficiency.
Navigating the future of global clinical trial logistics
The challenges facing clinical trial logistics in 2025 are unlikely to diminish as regulatory environments continue to evolve and global trial complexity increases. Success requires understanding not just the immediate operational challenges, but the strategic advantages that different geographic approaches can provide.
For US pharmaceutical companies managing global trials, the traditional approach of shipping everything from US operations may no longer be the most efficient or cost-effective strategy. The regulatory burden, time zone challenges, and compliance complexities highlighted throughout this year demonstrate the value of geographic diversification in logistics operations.
Companies that proactively address these challenges through strategic operational planning will maintain competitive advantages in trial timelines and budgets. As the industry continues to globalise and regulatory requirements become more complex, the importance of choosing logistics partners with true international expertise and operational flexibility will only increase.
The key to successful pharmaceutical logistics lies in understanding that one size does not fit all destinations, and that geographic strategy should be an integral part of trial planning from the earliest stages of protocol development.
How Greens can improve your clinical trial logisitics
Greens' dual UK and US operations are specifically designed to address these pharmaceutical supply chain challenges. Our strategic positioning allows US pharmaceutical companies to leverage UK-based production for European and international markets, bypassing many of the export control complexities and compliance burdens outlined above.
By combining local expertise in both jurisdictions with streamlined cross-border capabilities, we help clients build the geographic diversification and operational resilience that are proving essential for navigating today's complex regulatory environment.
