IN PARTNERSHIP S


ustainability has become more and more important in clinical trials, particularly in addressing the environmental impact of Investigational Medicinal Product


(IMP) distribution and laboratory diagnostics. Centralised and decentralised models, as well as hybrids of both, dominate these areas, each with unique benefits and limitations. By exploring their trade-offs and by smart integrating innovative online and real time technologies, we can achieve a balance between operational efficiency, cost effectiveness and sustainability. A rather new challenge is the fast-raising cell


and gene therapy (CGT), particularly autologous cell therapies that may require ultrafast transportation times round the globe. The sustainability and carbon footprint of a single treatment circle may be enormous. However, the high value of a single treatment may shift the focus more to high-end and the latest online/real-time technology to mitigate any risk for the product and higher costs for a more sustainable transport will become secondary compared to the value of cell and gene product.


The role of real-time technology in sustainable shipment monitoring Online cloud loggers with multi-parameter monitoring equipped with GPS, temperature, shock, light & humidity monitoring enable real-time tracking of shipments. These tools enhance accountability, ensure shipment integrity, and reduce waste caused by undetected transit issues, ensuring the integrity of IMPs and biological samples while minimizing waste and environmental impacts. Their integration supports a hybrid logistics model, bolstering sustainability in both centralised and decentralised approaches. Centralised systems for IMP distribution and


central labs for laboratory diagnostics offer several operational advantages, such as operational consistency: standardised processes ensure compliance, data reliability and quality, as well as reducing costs through resource pooling and waste reduction. However, the environmental trade-offs are substantial: long-distance shipping of IMPs and biological samples increases carbon footprints, especially with temperature-controlled logistics. Decentralised models, which bring IMP storage and diagnostics closer to trial sites, address some environmental concerns, such as reduced carbon


footprint and faster response times: Local labs and storage accelerate diagnostics and supply adjustments. Despite these advantages, decentralised models face critical hurdles: high fixed costs as multiple regional facilities demand significant investment and, more importantly, regulatory and operational challenges to ensure consistent quality across decentralised sites can be complex and resource intensive.


Hybrid models 2.0: a balanced approach including new real-time data technology The new hybrid logistics model combines the strengths of centralized and decentralized approaches, now substantially enhanced by Real-time data. Efficiency and scalability via centralised hubs streamline high-complexity operations, with local sustainability performed throughout regional facilities, which reduce transport distances and emissions.


Innovations driving sustainability in clinical trials and cell and gene therapy Combined innovative technologies are key: 1. Online cloud loggers for shipment monitoring: Real-time data on GPS location, temperature, shock, light and humidity status ensures shipment quality while identifying inefficiencies in transit.


2. High-end reusable packaging: Sustainable thermal packaging with VIP and PCM technology minimises packaging size and volume weight for airfreight saving costs and lowers carbon emissions.


3. Data-driven logistics: Route optimisation powered by AI reduces transit times and fuel consumption.


4. On-site capabilities: Portable diagnostic tools and local IMP storage reduce reliance on centralised hubs, cutting transportation demands.


The path forward: operational excellence and sustainability in harmony The healthcare industry must adopt a strategic approach to logistics that aligns with sustainability goals without compromising regulatory standards or patient safety. Advanced supply strategies, enhanced by real-time monitoring technologies, offers the flexibility and innovation required for sustainable growth.


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