Cold Chain Logistics: Essential Procedures for Clinical Trial Success
Cold chain logistics for clinical trials are constantly evolving as new technologies and developments are adapted. While multiple factors are responsible for reshaping the clinical trials supply chain landscape, the explosive evolution of biologics is one of the key drivers in order to preserve the integrity of biologics and other highly sensitive medicinal products, and to maintain the validity of trial results, cold chain solutions are essential.
Cold chain logistics involves the safe transport of temperature-sensitive products along the clinical trial supply chain to the investigator site. According to Grand View Research, the global healthcare cold chain third party logistics market size was estimated at USD 42,745.3 million in 2024 and is projected to reach USD 66,118.8 million by 2030, growing at a CAGR of 7.6% from 2025 to 2030. The market is growing due to the rising demand for temperature-sensitive pharmaceuticals, stringent regulatory requirements for drug storage and transportation, and the expansion of biologics and vaccine distribution worldwide.
Maintaining the investigational medicinal product’s (IMP) integrity across the entire supply chain, from packaging to storage to distribution is a rigorous process that requires cold chain and logistics expertise.
To maintain product integrity and meet with regulatory requirements, we outline below the key factors involved with successfully executing cold chain distribution in the clinical trial industry:
Planning & Risk Mitigation
Poor planning and neglecting the importance of identifying vulnerabilities of cold chain logistics can result in lost sales, productivity, and opportunity to improve patient lives. When working with a cold chain provider it is extremely important to take the time to identify a means of addressing issues should they arise.
Furthermore, planning and selecting the correct cold chain strategy, given the unique composition of the product and its destination, is necessary for ensuring that the clinical product does not become compromised. Delays and unforeseen temperature fluctuations that have not been discussed, accounted for, or have a clear contingency plan in place, can potentially place millions of future revenue dollars at risk.
Packaging and Delivery
Optimized shipping strategies and effective thermal packaging are critical for the delivery of temperature sensitive products. The biggest challenge associated with cold chain is maintaining the required temperature range throughout the delivery cycle; it should be noted that some biologics require storage in a much colder environment.
There are several variables that should be considered in order to ensure that a product is delivered without any variations in its composition, this includes identifying the correct size and type of package, temperature needs, the best route to the site, and the most effective temperature-control mechanism.
Monitoring
When shipping temperature-sensitive products, it is essential to have a monitoring system in place to allow for increased visibility and ensure that the products’ integrity is maintained throughout. Without this, control of the product is lost as it moves up the supply chain. Furthermore, if the product’s temperature does not remain within the required range, it could result in clinical trial delays and extra expenses. Sensor technologies, smart technologies, and recordable devices such as RFID tags are solutions that enable the monitoring and management of cold chain logistics from point A to point B.
Cold Chain Logistics Solutions from Oximio
At Oximio, we’ve been supporting cold chain logistics for over 20 years. We take the time to work with you to develop detailed plans and risk mitigation strategies to ensure that your study is not compromised as a result of mishandled shipments.
All our containers are not only reusable and environmentally friendly, but also capable of protecting and transporting valuable temperature-sensitive material with a full range of temperature requirements.
Monitoring your high-value products at every step is of utmost importance and by adhering to the highest industry standards, we ensure that your IMPs and valuable samples arrive at the investigation site in perfect condition.
To find out how we can support your clinical trial research, simply contact us.
