According to recent forecasts by Fortune Business Insights, the global clinical trials market is projected to reach nearly $100 billion in 2030. That represents huge growth – yet achieving it simply won’t be possible without sensible investment across the supply chain. When it comes to the transportation of clinical trial samples, the industry faces the same problems as the wider pharmaceutical market, but further intensified and complicated by the very nature of clinical trials. It’s important to understand both the similarities with the pharmaceutical cold chain, and the very different dynamics involved in transporting clinical trial samples, in order to evolve a robust and reliable system for shipping samples around the world.
Product Efficacy
First and foremost, clinical trial samples need to work at the point of delivery. This is the core rationale for all cold chain businesses; product efficacy is sacrosanct. The billions invested in biologic specimens, new vaccines or investigational drugs are worthless if they have failed by the time they reach patients. In the best-case scenario, they simply won’t work, skewing data and delaying regulatory validation. In the worst-case scenario, poorly protected samples may harm the patient. Whatever else you require from a clinical trials cold chain solution, product efficacy always comes first.
The Increasing Complexity of Clinical Trials
The rapid growth of the clinical trials market is due in part to the huge advances being made by researchers. Consider biologics, for example. Global Data reported in 2022 that sales of biologics will significantly overtake innovative small molecule sales by 2027 – a testament to the exciting work being done in this field. Of course, biologics are much more complex to transport. They are sensitive to heat and susceptible to microbial contamination, so maintaining a consistent ambient and secure environment during transit is even more important for biologics than other medicines. As biologics grow in influence and importance, cold increasingly becomes the new normal.
The Regulatory Framework
Accordingly, the safety-first mantra of any medicine is more strictly regulated when it comes to clinical trial samples. Regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have specific guidelines and regulations in place to ensure the quality and safety of samples. Typically, these regulations require strict temperature monitoring and documentation during transportation to demonstrate compliance.
At Once Global, and Local
At Once Global, and Local Clinical trials are increasingly conducted on a global scale, with samples transported across different countries and continents. This globalisation poses challenges in terms of maintaining temperature control during long-distance transportation and varying climates. At the same time, the smaller sample sizes of clinical trials compared to mass-market pharmaceuticals require a more agile, sub-pallet solution. These issues come together especially when you consider remote locations. How do you deliver clinical trials safely? You need the same robustness of cold chain solution to maintain internal temperatures and prevent damage in transit, but portable enough to ensure delivery wherever in the world it is needed – which might be in a region where, for example, access to electricity is fallible or non-existent. In short, a container that strikes the optimum balance between high performance, durability and optimised size and weight, is key.
