Clinical trials are essential to the development of drugs, diagnostics and medical devices. They provide evidence that a product is safe and effective, helping companies make informed decisions when launching new products in the market. Kitting—or the packaging of components for clinical trial use—is a major factor in the success of some clinical trials.
However, what many people don’t realize is that there are various risks associated with kitting for clinical trial products. To understand these risks and how to mitigate them, let’s look at what kitting entails.
What is Kitting?
Kitting involves preparing and consolidating trial materials, such as patient kits, sample collection kits, specimen labeling kits and other components necessary for use in clinical trials. Proper kitting can save time and money for clinical trial sponsors by reducing inventory costs and increasing efficiency throughout the entire process.
Unfortunately, there are several challenges and risks that must be considered when kitting for clinical trials. One of the most significant is accuracy; if any one component or packaging element is incorrect, the entire kit could be wasted. Additionally, all components must stay within temperature guidelines throughout transport to maintain potency and efficacy without any degradation. This can be especially difficult when dealing with highly sensitive items, such as vaccines.
As clinical trial managers rarely receive the protocol until after its approval, they must rely on vendors to supply kits quickly that include all the necessary components for the study to be a success. No two studies are exactly alike so it can be difficult to find a vendor who can provide a kit that fits your needs perfectly or be flexible in solutions. Here are essential questions you should ask when looking for your kitting partner to avoid challenges.
1 – What packaging capabilities do you offer?
First, ensure your vendor has the capabilities needed for your trial protocol. Do they have a qualified GxP site that includes packaging rooms or a dedicated kitting area? Depending upon your trial needs, it may be that your vendor needs to have separate rooms to kit different products. It is important to have that aligned first before moving forward with a vendor.
In some cases, your kitting partner may have recommendations if you reach out prior to designing your protocol. It is important to communicate with vendors as early as possible in the planning process to make sure they have everything in place to make your kitting run go smoothly.