We know it’s your priority to get your clinical trial in the hands of your patients — wherever they may be. And, it’s no small task. From site selection and patient enrollment to managing regulatory approval and ensuring the integrity of your trial data, your role is critical to the success of the study. If you are also responsible for the labeling of your trial drug you know that this is sometimes an afterthought or considered the final phase in the process, however, it is the key to the overall success of the trial.
A focus on pre-planning and following labeling best practices, will not only help you get your trial drug ready faster, but will ensure all regulatory requirements have been met and prevent any delays in study start-up.
As you begin the pre-planning phase, keep these elements in mind when thinking about your label needs:
- Plan early and communicate often.
The Bellwyck team will serve as an extension of your team. As we partner with you in the early stages of planning, we’ll want to understand the following: the overall scope of the labeling requirements; any tasks that may be on a critical path and may affect timelines; changes that may occur throughout the lifecycle of the project and how this may affect the supply needs as the study advances and grows in the future.
Consistent and ongoing communication is key. This will allow us to grow and develop with your trial, allow us to react quickly when changes are needed, and provide a greater chance for a successful trial.
- Protect the blind.
As the need for blinding in some clinical trials is key, ensuring to keep the packaging and labeling consistent and identical between the actual drug and the placebo is vitally important to maintaining the integrity of the study intact. This may include many things otherwise overlooked, such as color consistency within different batches of labels, the intensity used in the ink print, as well as the overall positioning of any printed element.
- Materials matter.
There are many types of materials being used in trials, from plastic bottles and glass vials to cartons made of many different formats. In addition to this, the temperature conditions these supplies will be maintained in, coincides with the materials you will want to use for the labels and their applicable adhesives. Whether you need special label materials and adhesives for cold temperatures, frozen temperatures or controlled room temperatures, choosing the right material is critical. For example, a vial under refrigerated temperatures versus a carton maintained under controlled room temperatures will determine what label stock and adhesives are required to maintain the highest quality and be in compliance with applicable standards.
All this will help to prevent waste and complications or mishaps down the road, such as lifting of labels, non-stick results, labels that absorb the moisture and cause the ink to bleed becoming unreadable. The Bellwyck team will help you determine exactly what is best suited for the materials being used and offer recommendations for the best labeling practices. While there are many standard labeling materials on-hand, the Bellwyck team can also special order the materials needed for any complex materials or projects.
- The details are in the text.
From small vials that require tiny text to blister cards that require a lot of copy, your Bellwyck team has seen it all. We are well versed in many different shapes and sizes of products and materials and are ready to provide alternative solutions you may not have thought of yet. Always leading with a patient-first approach, the team will help make sure the expiry dates, lot numbers, directions and dosage information are clearly marked for all patients and onsite staff to fill in. Your team will also look at all of the options available to you including barcode scanning, adding your logo to labels and rearranging text for better readability. Big or small, these are just a few of the details we’ll help you consider.
- Prepare for protocol changes.
The Bellwyck team knows that there are many factors in clinical trials that are constantly changing as your studies progress and develop. Factors such as adding countries and languages, changing dosage requirements, updating and extending expiry dates due to new shelf-life information, as well as changes in addresses — all require label changes. Some of the requirements can be assessed and planned for, some cannot, but Bellwyck remains flexible and will provide solutions to many of these ever-changing aspects of the trials. Make sure to keep your Bellwyck team up to date on any changes, small or large, as they may affect your supplies and you may not even know it.
The future of clinical trial labeling
We are always looking at new and innovative ways to fulfill your packaging and labeling needs. As we continuously explore exciting new technologies, we always have the end users in mind. Implementing technology simply for the sake of innovation is not our approach. It must improve the quality of the project, make a process more efficient or develop more accurate results before we will consider adding it to our capabilities. However, there are many exciting things we are keeping a close eye on. From bar code scanning and electronic monitoring of dosing regimens to smartphone integration. As these technologies advance, we’ll explore ways to bring them to you.
At Bellwyck, providing customization and flexibility is key. We understand how important quality, accuracy and fast turnarounds are in this world of clinical trials. We are problem solvers who look for the best solutions, and most efficient ways to save time and resources. We understand your changing circumstances require a partnership that is available and flexible throughout your study and we’re happy to be a true partner every step of the way.