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November 26, 2015

3 different ways to ship your Clinical Package

CTA runs the rule on what companies should consider when shipping clinical supplies

By Staff Writer

If you’re a pharmaceutical or a medical device company shipping products and supplies nationally or around the globe, what packaging and labelling techniques are right for you? Naturally that all depends on the type of study you’re conducting, and what your study needs. Here are tips and strategies on which packaging and labelling (P&L) methods companies should use when shipping their product.

 

Traditional Packaging & Labelling

For Traditional P&L, kits are built and labelled in batch prior to the start of distribution. Be warned that large blocks of time are required in production schedules and note that any unexpected changes can derail packaging schedules. Forecast models are needed for supplies while changes that occur after P&L will require a rework and more scheduling time. Distribution is simply pick and pack, however, more storage space is required. Strategies companies use will depend on whether all supplies are P&L, with bulk shipments sent to distribution depots, and if changes take place after P&L campaigns. If, for example, you had a global Phase III study, using single panel country specific labels, traditional P&L would be ideal for this.

 

Just-in-time (JIT) Packaging & Labelling

Similar to Traditional P&L, JIT supplies are packaged and labelled in large batches, except for some variable data (Protocol number, Expiry-Retest date), which is added at the point of distribution. JIT also allows supplies to be shared across multiple studies and reduces the risk of rework. Nevertheless, distribution becomes more complex as a Quality Assurance (QA) buy-in is required and more storage space is needed. Strategies for JIT all depend on whether your trial has multiple protocols and if you are pooling supplies. So if you have a sponsor who wants to use drug pooling across multiple protocols, and the kit is a single item, JIT P&L is ideal. With a 1-by kit the distribution employees would not need to open a kit, they could simply apply the ancillary label.

 

On-demand Packaging & Labelling

With On-demand P&L, kits are built and labelled upon shipping request. Any change in kit design mid-study is not a problem and higher or lower enrolment does not matter. Furthermore, no rework of a packaged drug is needed, but a QA buy-in is required. Distribution is simple pick and pack, although large site seedings can be a challenge. Like JIT, strategies depend on multiple protocols, pooling supplies, and also rely on conservation of supplies. So if you have a US based trial with patient specific dosing being delivered weekly directly to the home, On-demand P&L would allow studies to take place that otherwise may have been too costly or time consuming.

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