In our Label Design for Clinical Trial Supplies department, we exclusively design labels for clinical trials. Since the department’s creation in 2011, we have established processes, checklists, and specifications that we have continuously analyzed and optimized under a Continuous Improvement Process (CIP). This customized infrastructure accompanies every order and provides the data basis required for various statistics. One of these statistics relates to the page count of our booklet labels for IMPs. From this evaluation, a trend toward more content pages can be identified.
Clinical trials, especially Phase III ones, take place in many medical facilities simultaneously, and usually in different countries. Accommodating each country’s language in booklet labels takes space – nothing new there. So multi-national trials are now the norm, but the number of countries involved is increasing. Behind the growing internationalization of trails trail coordinators often mention three reasons:
Customized Medicine
Many drugs and therapies do not work the same for all patients. Individual factors such as genes, lifestyle, gender, and age can often play a role. Customized medicine focuses on the unique-ness of patients and looks at the individual characteristics of those affected. One challenge in personalizing therapies is the smaller number of patients involved. Recruiting trial participants from many countries is necessary to determine any therapy’s safety and efficacy profile.
Rare Diseases
A similar issue arises when researching drugs for rare diseases. Because of the small number of people affected and experts who can care for those suffering from that particular rare disease, the scope of clinical trials has to be multinational.
National Authorizations
In addition, investigational medicinal products and therapies must meet the legal requirements of licensing authorities. For drugs to be authorized in certain countries, the trials required must involve clinical trial units in the respective patients’ countries.
Amongst other measures, the Faubel Group reacted to the trend towards thicker booklet labels by hiring media designers and proof-readers to join Label Design for Clinical Trial Supplies and by purchasing an additional machine to manufacture booklet labels. Located in the Further Processing Labels department, this machine adds package inserts to adhesive roll labels.
I am sure that with all these measures, we will be able to compensate for the growing workload and meet agreed timelines, even given the current trend.
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