Reusable Shippers Draw Interest in the Clinical Trial Community
With shipper selection more important than ever in the clinical trial industry, we need to address the question: single-use shippers or reusable shippers? As it stands now, Biopharma companies are demanding highly robust shipping systems, while expressing concern about the cost to purchase and dispose of single-use shippers. Disposal of such shippers is a burden on storage-starved investigator sites as well as the environment. These concerns are leading to a shift away from traditional water-based shipping solutions to smaller, sophisticated, robust and reusable shippers, but are they really the answer?
In order to find out, Fisher Clinical Services conducted research of its own to understand the industry's needs and pain points through rigorous testing and to identify the best solutions to cold supply chain challenges. I’d like to tell you about two of our studies.
The first was about qualifying passive shippers by evaluating their ability to prevent temperature excursions on worst-case routes representative of real-life Europe, U.S. and international shipping conditions.
By “worst-case” and “real-life,” I’m taking into consideration the hottest and coldest climatic conditions, as well as contingency for complex and unpredictable variables – potential customs clearance issues, flight delays or cancellations, extreme weather patterns and natural disasters (we conducted this experiment thanks to double-digit growth in cold-chain products). If the shipper can maintain temperature for the expected duration under these most challenging conditions, it can be expected to perform as well as or better in all other less challenging conditions. This approach is often referred to as a bracketing approach to qualification and gives the highest assurance that the shipper selected for any chosen transit lane will deliver the product within the correct temperature.
The second study took place last year. Fisher Clinical Services partnered with a sponsor on a pilot program using high-performance, phase change material (PCM) reusable shippers. The results were encouraging. In addition to resulting in a lower temperature excursion rate and greater contingency for delays than traditional, single-use shippers, the reusable shippers were lighter and cheaper to ship. The reusable shippers compensated for their higher initial price tag by significantly reducing waste and environmental impact.
The sponsor estimated that the use of reusable shippers would divert 300,000 pounds of waste from landfill in year one, with a targeted reduction of 1.2 million pounds diverted from landfill in year two. Investigator sites similarly gave their thumbs-up, citing the reduced burden and expense of shipper storage and disposal. Everyone won – the sponsor, logistics provider, investigator site and ultimately the patient.
So, what do you think? Which shipper wins - single-use shippers or reusable shippers?