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Critical Considerations when Designing Shipper Solutions for Clinical Trials

The shipping of high-value, potentially lifesaving clinical trial pharma payloads requires expertly engineered, specialist solutions to ensure the precious products are protected and maintain their efficacy end to end. Due to this, there are numerous components and challenges to consider.

Designing the products deployed for clinical trials requires several

critical considerations to meet the necessary criteria including:

  • High-performing materials and insulators
  • High-performing, stable coolants, for example, using PCMs
  • Ability to meet regulatory requirements
  • Packing efficiency for the pharma client
  • Volumetric consideration
  • Be lightweight
  • Be user/patient-friendly
  • Demonstrate sustainability and recyclability capabilities

Before engineering a packaging product, which must meet the exacting requirements of a specific clinical trial, it is important product designers have an in-depth understanding of the marketplace the product will operate within and how it will be utilised within a designated clinical trial. With a pandemic there is an accelerated rise in patient-centric clinical trials, it’s important to consider the end-user or participant, alongside the warehouse teams that will handle the packaging, in addition to the latest regulatory requirements within that market space. There are also cost considerations, which when collectively combined, will help set the design boundaries for product engineers to work within. When designing packaging products for deployment within the clinical trials space, it’s essential to acknowledge the often vastly varying timescales involved within different trials. It can often take an extended length of time for a pharma product to be at the stage when it is ready for transportation and distribution, which might be due to the trial progress, necessary research, or issues within the trial project space. In clinical trials, it’s imperative any risks are mitigated to help ensure the pharma product is delivered to the end user in its correct and safe state. With this consideration, we acknowledge that performance stability during transit is a very prominent consideration for the design process due to how long it might have taken a specific trial to get to the position of transporting the pharma product to trial participants/patients.

Product performance stability requirements can relate to temperature stability, mechanical stability, and temperature duration in conjunction with any of the travel and transportation considerations, whether that be routing or customs considerations or transit times – they all need to be fully understood and appreciated specifically for clinical trial requirements. From a design standpoint, the budget must also be a key consideration, because often within clinical trials, the funding route is a sensitive consideration. Therefore, from a technical design point of view, it’s essential to achieve a balance between the product performance and stability with the cost, otherwise, the product may not be successful.

Clinical Trial Challenges

When producing packaging for clinical trials and the pharma logistics sector there are several potential challenges. When developing temperature-controlled packaging (TCP) it can be easy to get drawn into solving all design challenges that have ever been experienced but it is quite important that the boundaries enable the engineer to deliver an excellent product but not to over-engineer and risk missing the original issue. The product design needs to focus on meeting the crucial needs first and if it isn’t a problem in the real world, it shouldn’t be assumed it is a problem because a product designer has seen it in the design space. If this isn’t managed carefully during the project process the proposed product could then end up being too expensive or too heavy for example. Clinical trial packaging product development must meet regulatory requirements, so it is vital to design teams to understand all the latest regulations that need to be adhered to. The product must also meet the necessary mechanical and thermal requirements, particularly within clinical trials.