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International Clinical Trials

Designer Label

 

Customised documentation and label solutions offer potential for savings and administrative simplification when conducting clinical trials which serve patients in many countries. Organising user information and handling the labelling of test samples for large-scale studies is a demanding process. The studies are often conducted as a multicentre trial at different geographic locations, and increasing amounts of text, administration of several languages and a continuous focus on timelines are additional stress factors. Challenges during the labelling process of clinical trials also include: hundreds or thousands of subjects (Phases 3 and 4), a lack of internal resources to design, print and administer information; a risk of mixing up labels; and a need for a high level of security.

Labelling processes are typically handled in-house in research departments or by a CRO. Organisations take care of all the processes themselves – including their own design layout, language localisation and so on. Labels are printed in a simple one-layer format, for example on a thermal transfer printer. There are no economies of scale because it is rarely the same department that conducts larger scale trials on a regular basis. Further to this, a number of different labels need to be printed and administered. The process of labelling trial samples might include:

  • Creating text for labels and patient information leaflets, and getting it translated
  • Layout of labels
  • Typesetting text and arranging proofs (in different languages)
  • Printing the labels
  • Printing variable data (batch expiry, data, code)
  • Numbering (random or consecutive)
  • Label application
  • Administration

In recent years solutions have been created to take the pain out of labelling. The whole process, from design and layout to the delivery of the finished labels for trial samples, can be outsourced. In many cases such solutions lead to significant savings and simpler processes. For example, just one outsourced booklet or leaflet label might replace 10 to 20 standard labels, depending on the amount of information required.

All-in-One

A tailor-made label solution can be found for the vast majority of clinical studies. The choice of label type depends on the required quantity of user information, the container, safety requirements, documentation and many other factors. Instead of multiple variants of standard labels and patient information leafl ets, a typical solution for Phase 3 and Phase 4 trials is an all-in-one booklet label that can be supplied with around 100 pages. This allows space for a great deal of information in many languages and can be adjusted to a format suitable for any type of packaging. These labels can be designed and equipped with one removable label or more to apply to documentation, such as patient records. Booklet labels can be applied mechanically or manually according to customer requirements.

Outsourcing Shortens Delivery Time

The whole process, from design and layout to the delivery of the finished labels for trial samples, can be outsourced to labelling specialists, not only resulting in a quicker turnaround time but enabling companies to free up internal administrative time.

As requirements for clinical trials may be highly individual and different from the usual label solutions for the pharmaceutical industry, it is important to choose a partner that can handle the entire process, from layout to delivery of the end product. Partners with a dedicated team and expertise within clinical trials can achieve artwork turnaround in 24 hours and supply of booklet labels within a maximum of 15 days. Successful outsourcing means that all the client has to do is proofread and finally apply the labels on the drugs. Many suppliers offer the opportunity to imprint variable data, such as randomised and sequential coding onto the labels with the additional benefi t of 100 per cent inspection procedures to ensure accuracy. Through a choice of labelling materials, labels can be produced to enable the application of handwritten notes for individual patients.

Safer Trials with Increased Adherence

Outsourcing of such a vital process should not only be a matter of trust, but also security. Selecting a supplier that meets the requirements of current good manufacturing practices for secondary packaging (cGMP) will guarantee labels are produced with line clearance and full batch documentation. 

A number of features can be added to the label solutions to support trial safety. For example, a ‘tear-off’ label can be removed and easily placed in the journal for registration and reference purposes. Doseguard technology offers childresistant and senior-friendly solutions for blister packs, and a label with security die-cut or void sealing can eliminate the risk of tampering. Label solutions might also aid drug delivery adherence. In the case of booklet labels, user instructions are maintained with the product and there is a reduced risk of mixing up user instructions as text in different languages can be printed on one sheet. Some suppliers also have production capabilities for blinded and unblinded study labelling.

Conclusion

Experience shows that in most cases it pays to outsource the labelling process of clinical test samples to an external partner; especially with bigger studies comprising international trials that would benefit from an all-in-one booklet label offering simplified label design – meaning less label variants and therefore reduced handling and administration. A number of extra features that are hard to add internally can also increase usability during the test studies. Research departments and CROs can save valuable time and money from outsourcing, and also achieve increased security, functionality and patient drug adherence through using solutions from a trusted labelling partner.


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Pernille Smith is Clinical Trial Specialist and product specialist at CCL Label Healthcare in Copenhagen, Denmark. For many years, Pernille has worked with expanded label solutions for the pharmaceutical and biotech industry. Recently, she has been promoting CCL Label’s expansion into label solutions for the clinical trial sector. She has extensive experience in supervising healthcare organisations in outsourcing their labelling processes.

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