Chiara Venuti

As the healthcare sector embraces innovative therapies for rare and complex diseases, cold chain management has become a cornerstone of clinical trial success. Temperature-sensitive products, including biologics, vaccines, and cell therapies, must be carefully stored, transported, and handled to preserve their stability. However, pharmaceutical companies face numerous logistical challenges, from infrastructure limitations and high costs to regulatory complexities. As a result, up to 30% of temperature-sensitive clinical trial shipments experience temperature excursions during transit or storage. This is not merely a logistical concern; it is a critical patient safety issue.

This session will explore how pharmaceutical companies can proactively manage cold chain risks, ensuring investigational products reach clinical trial sites safely and reliably.

Key discussion points include:

• Handling errors at sites: Training clinical site staff and implementing standardised procedures to prevent mishandling of temperature-sensitive products.
• Monitoring and documentation: Using real-time temperature monitoring, digital logs, and compliance systems to track every shipment accurately.
• Contingency and backup planning: Developing robust emergency protocols for power failures, transport delays, and other unexpected disruptions to maintain the integrity of clinical trial supplies.