Written by Citation Expert: Stephanie Gajeski, Manager of Project Management

One of the biggest pain points facing Clinical Trial timelines today is the booklet labeling process. Labels are the last component needed before packaging can be completed, and there is often a late-in-the-game scramble to get booklet labels to the packager quick enough to avoid patient impact. Booklet labels tend to be an exasperating component.

However, they’re a necessary component. Booklet labels are still the most efficient way to deliver to markets around the world. They can contain product information organized in a few versions for upwards of 40 countries in one tiny booklet. They can house verbose regulatory requirements on a tiny vial that a single panel label just can’t manage. They are not going away anytime soon.

With an essential mechanism to clinical trials such as a booklet label, the industry is always looking for ways to cut down on the two worst elements: Cost and Timing. Booklet labels have much higher costs associated with them than single panel labels do. While a single panel label focuses on the stock and adhesive, a booklet is a more complicated product with the leaflet insert construction, base label construction, folding, gluing and a lamination film layer. It’s a complex, time extensive, high cost process. It becomes nearly impossible to complete a booklet print production project in less than four weeks, and that can extend significantly depending on specifications.

Unforeseen catastrophes are another obstacle that can impact costs and timelines, as they are rarely accounted for in the budget planning or forecasting processes. Therefore, if an unforeseen catastrophe occurs and budgets aren’t prepared to handle the cost of replacement kits, many companies are unable to move forward with the trial, which means that fewer patients are able to participate. Or, even if their budgets can accommodate the replacement kits, the booklets might not be able to be produced in the short window between the catastrophe and the trial. This can actually mean the difference between life and death for some patients included in the trials.

  1. Buy in Bulk
    This is why when forecasting isn’t reliable, ordering a bulk inventory can be a sponsor’s safety net.

While it’s not necessarily a secret that a numerous amount of production costs are fixed, it’s not exactly common knowledge either. Each time a booklet press is turned on, it must go through the same process. Materials, plates, inks, clearances, calibrations, perforating, folding, gluing, laminating, die-cutting, etc. That’s just to name a few. There are so many processes associated with a booklet run, that the cost of the materials themselves start to be outshone by the production. What this means, is that whether 100 booklets are ordered, or 500, the extended price is going to be comparable. That extra few feet of booklet and base label stock doesn’t make or break the price. This is why, in terms of unit cost, the price is lowered as the quantity rises.

It is more beneficial for both the customer and the vendor to do one run of, for example, 1,000 labels rather than two runs of 500. In fact, two separate runs would cost almost double what the single larger run would. The fixed costs of production support higher volume for a lower price. A difference in quantity of 100 to almost 1,000 is minimal in comparison to the full cost.

*prices to demonstrate difference per quantity only.

In terms of budgeting, this is where bulk ordering can win out over forecasting on a small scale. It might not be known whether or not a second campaign of a booklet type will be needed at the time of ordering. However, if the first rollout of a project is 500 labels, there can be a safety net of another 500 labels for a negligible difference. This means that if an unexpected second rollout comes around; variable printed labels can be available in literally half the time that the first rollout took.

  1. Utilize Citation’s Label Storage Program
    There is also another strategy to consider that impacts total cost. Occasionally, there is the realization that the booklet part has been under-ordered due to a late scope change, problems in the packaging room, or a bad application that has consumed a high number of labels. Any of these issues can create a precarious situation. There are plenty of worst-case scenarios that can lead to needing a quick turnaround of booklets to avoid the patient being impacted. When those scenarios hit, no one wants an additional full price production run and a multiple week timeline.

Citation Healthcare Labels has made it a practice to offer an alternative quantity suggestion at the time of order placement. CHL offers expertise in regard to smart ordering an optimal quantity by leveraging our product knowledge and consulting for our customers.

If a client decides to order a higher inventory, Citation inventories this printed product for a low cost for two years in our Approved Label Storage facility. This is logged and inventoried through our Inventory Management software. Clinical Labels are constantly evolving to stay current, and booklet labels will continue to be current for the unforeseen future. Thinking smarter about how they are approached, and becoming more innovative, will be what keeps them in the game.