Answering These 5 Questions Will Save Time and Budget
Sarah is about to participate in a clinical trial. As she sits with her doctor, she learns that her particular trial will require 30 injections per month, which could overwhelm even the most experienced patient. However, Sarah is relieved when her doctor explains they’ll meet weekly to answer questions and assess her progress. As she leaves the office with a kit that includes a week’s worth of vials, she’s ready to confidently take on her disease one day at a time.
We know Sarah’s story all too well. In fact, these scenarios are what drive our packaging strategies at the onset of a project. Our goal is to always align your packaging with how your trial is planned to be run. Sharing the details of your plan with your Bellwyck team will not only keep us informed and ready to tackle your needs, but will also save you time and money as we explore the many elements of your trial.
While every study is unique, we start every relationship with the same general questions.
Protecting the integrity of your product is critical. From guarding your drug from light or packaging it in extreme temperatures to maintain stability or utilizing blister packs for easy use, our experts have the knowledge to help you determine the right packaging needs to save you time and budget. Knowing these details well in advance will allow us to source the right materials and present the right solutions for your study.
While reducing waste is always a priority, when it comes to an expensive drug or one that is in short supply, it’s even more critical to limit overage. Providing our team with this information will allow them to determine the most efficient and effective kit size to provide each patient.
Our understanding of how the drug will be administered to the patient is critical when we are determining your packaging and kit needs. In Sarah’s case, the study she participated in required 30 injections per month. Instead of sending the patient home with 30 vials, we discussed many options with the drug sponsor and determined that her doctor would meet with her weekly. To simplify things and minimize the value of the drug being held by the patient, we determined a weekly kit was the best choice for this trial’s success and allowed Sarah to feel more confident in taking on her treatment at home.
The complexity of the dosing is equally important in determining packaging needs. Patient compliance to the protocol is critical and our team can help design packaging to ensure that patients are taking the right dose at the right time. For example, does the patient need to take two pills in the morning and two in the evening and are the strengths blinded? In this case, we’d likely utilize a wallet card with blisters that will clearly layout the dosing for the patient, so they know exactly what to take and when.
Three major things to consider when thinking about labeling are compliance, storage and usage conditions, and details of the product itself.
From a compliance perspective: Meeting the regulatory requirements and ensuring label accuracy saves lives. While regulatory groups dictate requirements per country and sponsors are ultimately responsible for checking for accuracy, our team serves as another set of eyes and often spots issues, raises any concerns or alerts the sponsor of common practices as the project unfolds.
Extreme storage and usage conditions can be tough on labels. Does it need to be waterproof? Will it be stored in extreme temperatures? Our team will work with yours to determine how to protect your label by utilizing the proper materials, adhesives and inks.
Product size, shape and appearance is critical in determining what label can be used. Does the product have an irregular shape (such as a tube of ointment)? Is the product very small with little surface area to apply a label? Does the product already contain an identifying mark or an existing label that needs to be covered or removed? If your Bellwyck team knows what they’ll be working with ahead of time, we can incorporate these details into our packaging plan in advance, which can help save time and money.
The participation in clinical trials can be complex and overwhelming to the patient, but an informed and confident patient who understands clearly how to administer a drug will produce more accurate trial results. There is rarely one packaging and labeling strategy that works in every situation. Bringing us in during the early planning phase will help us dive deep into your needs as we examine your specific trial variables. We’ll help you simplify the process and get your product to sites as quickly and as cost effectively as possible.
The Bellwyck Pharma Services
Project Management Team