Clinical Trial Labeling: Don’t Get Stuck

by Dan McDonald
Bottles that have been labeled for clinical trials

Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component.

Did you know that product labels are big business? Labels are a lively commercial niche, and the global market for pharmaceutical labels is now $9.59 billion, and it’s growing at a steady rate.

When it comes to clinical trials, labeling falls under strict licensing requirements mandated by agencies across the world to ensure standards are met, such as proper usage and patient safety. No surprise there. Clearly, clinical trial labeling brings with it complexities and timeline concerns.


Things Get Tricky With Drug Labels

An especially critical part of the clinical trial labeling market are labels created for packaged investigational and approved drugs.

Most drug packaging vendors also supply the labels. But this isn’t required—in fact, the separation of label development and packaging can offer advantages and help accelerate label manufacturing and distribution.

Imperial was recently contracted to supply 100-count bottles of vitamin D for a liver disease study. Some of the study participants would be taking vitamin D in addition to the study drug.

Our logistics team recommended labels to comply with customs requirements. The vitamin D manufacturer kindly supplied sample label text.

Our team saw right away that the text we were given had issues if used for clinical trial participants. It appeared to be the manufacturer’s generic fill-in-the-blanks label for the general public, and the text would never pass scrutiny for a clinical trial.

For example, it directed the participant to contact their primary care physician if they experience an adverse event. No mention of the study doctor.

We requested the study protocol and rewrote the label content from scratch. The label was rewritten using plain language so a clinical trial participant could easily understand and follow the information. The label content also included specific information related to this clinical trial.

Imperial’s creative and language services manager Erica Manning sums it up:

“Had the CRO used a different vendor, it is quite likely there would have been holdups in customs or issues getting EC approvals, leading to wasted time and materials plus a long delay.”


Simplifying And Streamlining

When considering the different steps in label design, translation, and formatting, companies can see significant savings by utilizing a single vendor. A single vendor can streamline the process and save time.

Using a single vendor for multiple services eliminates the need to hand pieces of the project from one vendor to another, which reduces meetings, explanations, and vendor management.

One of the great streamlining advantages of using a single vendor (like Imperial!) is that the different components of the process work in sync. Teams at each step of the process consider and communicate with the previous step and the next step.

Everyone has a vested interest in the project as a whole – not just their own part. This is a sound formula for success.


Translation Is Tricky For Clinical Trial Labeling

Many companies complain that the translation process often delays other critical elements of supply distribution. The following example occurs frequently. As a rule, English text, when translated, requires many more characters. In other words, the translated text is much longer than the original text.

Unfortunately, the translation company is myopically concerned with just its own piece of the pie. It sends the translated text to the sponsor or CRO, who sends it to the printing company, who formats and goes to print the labels but finds the text has exceeded the space limitations. It won’t fit. The result? More delays.


The Imperial CRS Advantage

Combining development, design, translation, and printing under one roof ensures that content, design, translation, and associated formatting are performed within one company, working in harmony as one work stream. This tends to reduce time and ensures that each stage of the process is coordinated with the next.

Label development is essential and complex, and we can help. So, don’t go it alone! Contact us for more information on how we can help with your clinical trial labeling.

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