One of the most critical elements of running a successful clinical trial is ensuring the uninterrupted supply of drug products and ancillaries. Any disruption in the supply chain can lead to significant delays, increased costs and can ultimately jeopardise the trial if the patient dosing dates are not met. Sourcing teams work diligently to establish robust supply chains that guarantee quality while keeping expenses in check. However, there is one often-overlooked factor that can present unexpected challenges—space.
Not all clinical sites have the storage capacity to accommodate drug products and ancillaries for every clinical trial. So, what can be done when space is limited? One effective solution is kitting. This involves packaging all or some of the essential items a patient will need during a clinical trial into a single box. These kits are typically organized per patient, per site visit, or per dosing session and are then sent to clinical sites for use, however before kitting, consideration must be given to account for overage. If a kit contains only the exact number of ancillaries needed and one becomes damaged, you do not want to cause a dosing delay.
Why Consider Kitting?
Let’s explore a hypothetical scenario. Imagine you’re managing a clinical trial that requires drug storage at controlled ambient temperatures. Additionally, you need ancillaries such as syringes, alcohol wipes, cotton pads, and gloves. The trial spans 25 clinical sites across 15 countries, requiring precise coordination of supplies.
Traditionally, to ensure each site has enough stock, you might order multiple boxes of each ancillary item. Ancillaries usually come in bulk, for example, 100 syringes in a carton. However, many sites may only have a handful of participating patients, making it impractical to store large quantities of supplies. If there is only a handful of syringes required at a clinical site within a year, the remaining ancillary box will end up expiring and be wasted. If storage is already limited, accommodating numerous boxes becomes a logistical nightmare.
A smarter approach? Kitting. By assembling patient-specific kits that include all required items for each visit, you can streamline logistics and optimize space.
Benefits of Kitting
Kitting is not limited to ambient drug products and ancillaries. Here are two real-world examples where kitting provided an effective solution to our clients' challenges.
Case Study 1: Ancillary Storage Limitations
Ancillary supplies often arrive in bulky packaging, leading to excessive overstock. One client running a liver disease clinical trial required specific items per patient, including syringe, two different needle sizes, zip-lock bags, and labels. Ordering full boxes for each of the 89 clinical sites would have resulted in unnecessary stockpiling and significant storage challenges, alongside significant and unnecessary costs to purchase the full boxes.
To solve this, we developed bespoke patient-ready kits containing only the required items. Given the trial’s global reach across 26 countries, we created 14 different SKUs tailored to regulatory and logistical requirements. Our production team then assembled and shipped these customized kits, reducing costs, optimizing storage, and enhancing site efficiency. Had the client proceeded to ship 2 boxes of needles, 1 box of syringes, 1 box of labels, and 1 box of zip bags, the storage space required would have been 4,339.4cm3 in an already limited storage room. Each of our kits required just 878.14cm3 which was a saving of 80% to the clinical sites which only had 1 patient enrolled in the trial. The client was also able to save on logistics costs by shipping less boxes to each clinical site.
Case Study 2: Ultra-Low Temperature Storage Constraints
A client running an oncology trial faced a significant issue—clinical sites had extremely limited ultra-low-temperature freezer space. The sites needed to store as many vials as possible without wastage, but the design of the current vial boxes took up a considerable amount of space. Each box was square and contained 64 vials, this resulted in the small freezer being filled with one single box. Given budget constraints and storage room at the clinical site, purchasing additional freezers was not an option, so we had to create an innovative solution.
Our solution? Optimized kitting.
We designed kits that maximized the available freezer space while ensuring the integrity of the drug product. Our team designed a rectangular kit capable of storing 8 vials in rows of 2; this ensured each kit held a full patient trial dosage, which reduced the chances of a dosing error. The kits would then be able to fit into the freezer space in a way that would reduce the amount of gaps and unoccupied space (see diagram). The kits, once finalized, were packed over dry ice into these customized kits and shipped to four clinical sites. In total, 600 kits were successfully delivered, enabling the trial to proceed smoothly without additional storage investments. Not all 600 kits were required at once, the kits remained in storage at RxSource and were shipped to the clinical sites, as and when they were required. Ensuring that the kits were packed into custom kits, ensured that the clinical sites were able to store enough kits for each dosing date, for all patients, without having to schedule patient dosing dates on different days, due to storage limitations.
When Kitting Isn't Necessary
Are there situations where kitting may not be the best solution? Yes. To determine if kitting is necessary, a cost-versus-space analysis should be conducted. Does the space saved by kitting justify the cost of assembling the kits? If each clinical site is likely to use most of the items in an ancillary box, the space savings may be minimal, while the added costs could be unnecessary.
Additionally, some clinical sites may be able to provide their own ancillaries, making kitting redundant.
Conclusion
As these case studies illustrate, kitting is a highly effective strategy for overcoming logistical and storage challenges in clinical trials. By optimizing space, reducing costs, and streamlining operations, kitting offers a practical solution to ensure the smooth execution of clinical trials worldwide.
When faced with storage constraints or logistical inefficiencies, the question isn’t to kit or not to kit—it’s how best to implement kitting for maximum benefit.
About the author
Kimberley Cooper is a Project Manager at RxSource. She joined the company almost 3 years ago and has over 13 years of experience within the industry.
Connect with KimberleyLast quarter alone, we were able to positively impact the lives of 44,500 patients. Our goal is to improve the lives of 10 million patients in 10 years. Contact us today to learn more about how we can work together to make a meaningful impact.
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