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Key Considerations For Clinical Trial Labeling

June 1, 2021

Clinical trials play a vital role in the healthcare sector. The data gleaned from these clinical trials can provide priceless insight into potential new treatments, allowing pharmaceuticals to be safely released on the market or delayed for additional testing. Clinical trials may provide ways to prevent medical issues, identify new diseases early on, or improve health outcomes for specific groups of people.

We've seen just how crucial clinical trials can be during the pandemic. The data gathered from vaccination clinical trials proved just how effective COVID-19 inoculation can be, allowing vaccines to be safely and rapidly released in the interest of public health. But of course, clinical trials are vital in the development and distribution of all kinds of medications and recommended treatments.

As such, pharmaceutical labeling requirements for clinical trial applications must be followed. There are numerous challenges your organization may face when developing pharmaceutical labels for clinical trials. To combat these challenges, it's recommended that you work with a label printing company that has ample experience in this sector. Let's take a closer look at some of the considerations you'll want to keep in mind as you weigh your options for clinical trial label design.

Error Inspection Remains a Top Priority

A report published by the Institute of Medicine found that labeling and packaging issues were the root cause of 33% of all medication errors. In order to prevent potential health risks during clinical trials, it's imperative that you work with a detail-oriented label printing company committed to preventing these kinds of errors from the start.

Inspecting these labels by human sight is not sufficient. Instead, state-of-the-art technology must be employed to avoid and identify even the smallest printing and labeling errors. Be sure to choose a label printing company that utilizes machine vision in-line and off-line inspection systems, OCR/OCV readers, and spectrophotometers to maintain quality control. These procedures can provide you with the reassurance necessary to carry out high-quality, compliant clinical trials.

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Versatile Label Formats Provide Flexibility

Every clinical trial will come with different requirements. Not only do container choices vary, but so do the specifications of each trial. Some situations may require expanded content labels, such as booklet labels or wrap labels to provide adequate information for providers and participants. Others may require something a bit simpler in terms of label design but may require black-out or completely opaque labels. When partnering with a label printing company, you'll want to determine the variety of label options they offer and assess whether the formats they have available will meet (or even exceed) your expectations. A label company that offers a number of options can allow you to form a lasting relationship for multiple trials or phases.

Adhesive Selection May Complicate Matters

Choosing the right label format for your clinical trial is just one piece of the puzzle. You may also need to select the best adhesive for those clinical trial labels. This can be a complicated process, in some situations, because you will need to factor in the length of the trial, the type of container being used, and the conditions under which the product will be stored. The container material will have a big impact on this decision, as the type of adhesive selected for plastics will differ from the best option for glass containers. The shape or width of the vial, as well as the moisture conditions of a given storage space, will allow you to make the right decision. Make sure your label printing company can accommodate your specific adhesive needs, if applicable.

Multilingual Labeling Demand Increases

Although many of us tend to view clinical trials only through a national lens, the reality is that multilingual labeling is essential both within the U.S. and abroad. Not only are clinical trials becoming increasingly multinational, but so many languages other than English are readily spoken in our own country. To ensure information is communicated effectively and accurately, you should consider multilingual labeling as part of this process -- especially if you plan to expand your market beyond the United States. Label information must be translated precisely and in adherence with local ordinances or regulatory agencies. Including multiple languages as part of your labeling will ensure patients and physicians fully understand essential instructions, allowing for a higher quality of patient care.

Tamper-Evident Labels Maintain Safety For All

Of course, clinical trials do come with their fair share of risks. Participants do assume some level of risk when they agree to partake in these initial stages of research and testing. However, it's vital that patients aren't unknowingly taking other risks with their health through their participation. Maintaining patient health and safety is understandably a top priority. Tamper-evident labeling and packaging can play a major role in this area. Some label companies may offer the inclusion of a film that will break or distort, preventing the label from being reapplied to the container, in the event of potential tampering or other hazards. These kinds of design features make it much easier for practitioners to spot possible threats and discard pharmaceuticals accordingly, putting them in a better position to protect patient health.

An increase in clinical trial prevalence is good news for researchers and the general public. That said, it's imperative that clinical trial teams ensure their labeling and packaging aligns with all regulations and industry standards while facilitating the best possible patient outcomes. By choosing an experienced label printing company that prioritizes error reduction, versatile label formats and adhesives, multilingual label design, and tamper evident tape or labels, you can more thoroughly meet the demands of healthcare professionals, patients, and sponsors.

As the demand for drug development increases, the pressure will continue to mount. Without the right clinical trial labeling and packaging materials, you could risk the success of your clinical trial. Fortunately, you won't have to worry about that when you do your homework and ensure the label provider you choose addresses all of the concerns outlined above. Of course, you'll also want to work with pharmaceutical labeling companies that can operate on your tight timeline while providing superior results at an accessible price point. To learn more about what we can do for you, please contact our team today.

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