Selecting the Right Packaging & Kitting Partner: Essential Questions to AskPosted on 04/05/23
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.
2 – How quickly can you deliver materials for the trial?
Timelines are imperative for clinical trials. For custom-made kits, they must be created to accommodate each clinical trial’s protocol requirements, which often involves negotiating with vendors, who might have different ideas about what should go into the kit or how much it will cost. Vendors may not be willing or able to deliver the desired kitting solution within an appropriate timeframe. If your kits are not created in time, your trial can be delayed, missing the first patient dosage and wasting funds. It is also important for clinical managers to ensure that there are redundancies in place – what happens if something goes wrong or an item breaks during transit? Sticking to the timeline and having a flexible partner is key to a successful trial.
Complex study designs within a clinical trial coupled with tight timelines to meet immediate deadlines can leave you feeling rushed and under pressure. Myonex’s CTPD experts have the capacity and expertise cross-functionally to support and execute your packaging, labeling and distribution needs.
3 – Are there any special requirements or regulations that need to be met when it comes to packaging and shipping of clinical trial materials?
Kitting isn’t as simple as throwing items into a box, and your vendors must be GxP certified, have SOP’s in place, and are regularly audited to conduct kitting runs.
Considering this, it is essential for clinical trial managers to choose cautiously before selecting a vendor to create their clinical trial kits. Each item within the kit must follow regulations, and this will vary by country. Your vendor should know the requirements for each country and provide options to comply with that for your kits. At Myonex, we ensure the kits we produce meet specific country requirements and keep logistics in mind. When shipping out your trial kits, they will not get stuck in customs as we have done the research and have processes in place to get products safely to sites and patients.
With careful selection and proactive management strategies in place, sourcing quality clinical trial kits does not need to be an insurmountable obstacle for those involved.
Overall, kitting for clinical trial products is a complex process that requires careful consideration of all risks that come with it. By implementing proper protocols and following best practices, supply chain professionals can reduce the chance of costly errors or delays. At Myonex, we support your kitting projects and ensure everything runs smoothly through our Clinical Trial Packaging & Distribution solutions. Our dedicated project managers will communicate with you throughout the process and remain on your side until the very end of your trial as we take care of it all, so you don’t have to. Myonex is known for being a flexible partner, and we’ll get your study to meet timelines no matter how tight. As a packaging and distribution partner, we will help you meet the first patient in deadline while saving costs and freeing your time to focus on other trial elements. Contact us for a stress-free kitting run.