The depot difference and why location matters in clinical trials

A recent example of this evolution can be seen in Brazil, where the Brazilian Health Regulatory Agency (Anvisa) introduced Resolution No. 945/2024, which took effect in early 2025. This regulation simplifies clinical trial approvals by introducing tacit approvals for clinical trial dossiers, simultaneous submissions to regulatory authorities (Anvisa) and ethics review boards (CEP/CONEP), and pre-approval importation of investigational products, provided local compliance standards are met. 

These updates align Brazil’s processes with international guidelines, such as the International Council for Harmonisation’s (ICH) guideline for good clinical practice E6(R2), and create opportunities for sponsors to accelerate clinical development and gain a competitive edge in this growing market.

We view these regulatory shifts as opportunities to enhance the efficiency and resilience of clinical supply chains. “The introduction of Resolution No. 945/2024 in Brazil is a prime example of how mastering local regulations opens new possibilities for trial sponsors to accelerate clinical development and expand operations in Brazil’s growing clinical research market,” says Icaro De Paiva Gouveia, Depot Manager at World Courier in Brazil. “With our global depot network and deep regulatory expertise, we’re uniquely positioned to help sponsors navigate these changes and bring innovative therapies to patients faster.”

A global network built for excellence

 

World Courier operates the largest owned network in specialty logistics, with more than 120 facilities in over 50 countries, including 22 strategically located GxP-compliant depots. These state-of-the-art facilities are purpose-built to meet the stringent demands of clinical trials and specialty commercial products. From controlled ambient (15°C to 25°C) to cryogenic storage (below -150°C), our depots are equipped to handle a wide range of temperature-sensitive products, ensuring product integrity and safety throughout the supply chain.

“Our global depot network is the backbone of our clinical supply solutions service,” says Niall Eastwood, Director of Global Clinical Supplies at World Courier. “It allows us to provide seamless, end-to-end logistics support that ensures products reach patients on time and in optimal condition. This level of reliability and scalability is what sets us apart in the industry.”

Leveraging local expertise for global impact

The recent updates to Brazilian legislation underscore the importance of local expertise in navigating regulatory landscapes. By simplifying approvals and aligning with international standards, Resolution No. 945/2024 enhances Brazil’s appeal as a clinical trial destination, offering sponsors opportunities to reduce delays and accelerate trial initiation

However, taking full advantage of these opportunities requires an intimate understanding of local regulations and the ability to integrate them into a global supply chain strategy. “This is where World Courier excels,” Icaro explains. “Our depot in Brazil, along with our global network, ensures that sponsors can navigate these regulatory changes with confidence, minimizing risks and maximizing efficiency.”

Addressing the challenges of clinical supply chains

The clinical trial ecosystem is becoming increasingly complex, with trials now involving a median of 40 sites and over 1,200 participants across multiple regions[1]. These complexities are further compounded by geopolitical tensions, regulatory disparities, and the growing demand for decentralized clinical trials (DCTs). World Courier’s clinical supply solutions service is uniquely positioned to navigate these challenges, offering integrated solutions that combine transport, storage, and risk management procedures.

Key features of our clinical supply solutions service include:

 

• A unified quality management system (eQMS) ensures consistent procedures and regulatory compliance across all locations.
• Real-time inventory visibility through our depot portal provides 24/7 access to inventory data, empowering informed decision-making.
• Strategic inventory placement at depots reduces delays and enhance patient retention by ensuring timely delivery aligned with dosing schedules.
• Integrated solutions that combine depot and transport services to offer a full chain of custody, simplifying vendor management and reducing risks.

Accelerating innovation for patient impact

For pharmaceutical and biotech companies, the ability to expedite clinical trials is not just a competitive advantage — it is a lifeline for patients awaiting new therapies. By leveraging World Courier’s global depot network, sponsors can reduce time-to-market, optimize supply chain efficiency, and ensure the timely delivery of investigational products to trial sites.

“Our mission is to help our clients bring innovative therapies to patients faster,” says Icaro. “With the recent regulatory changes in Brazil and our unmatched logistics capabilities, we’re enabling sponsors to seize new opportunities and drive meaningful impact in the lives of patients.”

Why choose World Courier?

For over two decades, World Courier has been a trusted partner for pharmaceutical and biotech companies, helping them overcome logistical challenges and position their products where patients can be reached. As part of Cencora, we offer unmatched reliability, scalability, and innovation in pharmaceutical logistics solutions. Our integrated approach spans the entire product lifecycle, from early-stage development to commercialization, ensuring that therapies reach their full potential and positively impact patient outcomes.

By leveraging our expertise and infrastructure, you can build a resilient supply chain that not only meets today’s challenges but also positions your organization for long-term success in the dynamic world of clinical trials.