Introduction — The Stakes of Clinical Trial Labelling

The global clinical trials market is worth almost £74 billion with some estimates expecting this figure to almost double by 2035. However, high overheads, complex chains of custody and pressure for rapid patient rollout often mean that in order to maintain the financial health of a study, clinical research sites need to be ran with extreme efficiency.

Studies show that approximately 7.3% of all rejected samples in clinical settings can be attributed to labelling errors. In the precise and sensitive environment of a clinical laboratory, a failed test or batch caused by poor labelling wastes valuable time and resources and is often entirely avoidable.

The Unique Demands of Clinical Trial Labels

In clinical trial settings, labelling often acts as the keystone to a sample’s successful journey through different treatments, apparatus and sometimes, even locations.

Labels must also align with strict frameworks like ICH E6, while ensuring that sample labels are tracked against an internally recognised and easy-to-use system. Throw in potential hazards common in clinical trials such as extreme temperatures, autoclaves, solvents, repeated handling and abrasion and you present a difficult puzzle for laboratory supply chains to solve when selecting labels.

Instead of filling this guide with marketing buzzwords, we wanted to offer a practical, straightforward look at our product features built for the demands of clinical trials.

Tamper-Evidence

CILS offer a wide range of laboratory tamper evident label formats. In clinical trial settings where positive results are both heavily scrutinised by regulators and external bodies while also being the ideal outcome for research technicians and research funders, the opportunity for tampering can potentially cast doubt upon research outcomes.

The following tamper evident formats can be applied to clinical trial containers and equipment to add another layer of confidence to results:

1. Perforation Cap and Tube Labels – Splits upon the rotation of a cap or lid (for indicating whether a twist cap has been opened.
2. Permanent VOID Labels – Leaves a permanent trace of tampering when removed on substrate (suitable for sample vessels and associated paperwork holdings).
3. Eggshell Labels – Fragment upon attempted removal (for use cases where someone may attempt to replace a label maliciously).

Extreme Temperature Resistance

In studies using cell therapies, biobanking or experimental treatments, cryogenics are often a key facilitator for storage and sample freezing. Even where the extreme temperatures of cryogenics are not reached, most clinical trials will ask their labels to withstand some form of extreme cold, be that in traditional freezing, autoclaves or post-centrifugation processing.

At CILS, our cold and cryogenic labels are specially formulated to survive these temperatures, down to -196°C. Our labels can be formulated using materials best suited to the intense cold of standard freezers, ultra-low temperature freezers or liquid nitrogen storage, all while surviving multiple freeze-thaw cycles.

We can pair these materials with specialised adhesives for either temporary or permanent application, formulated for specific labware surfaces such as polypropylene tubes and well plates and much more.

Colour Coding

Perhaps the most rudimentary line of defence against miscategorisation is colour coded samples. In early stages of clinical trials, colour coding can help staff to instantly identify sample priority, study or destination.

CILS colour coded labels are compatible with any listed resistance requirement, ensuring that contrast is not lost even through the most hazardous environments. No need to worry about your technicians querying shades of red on sample tubes.

For manual cataloguing where sorting or categorisation is done by hand, our colour coding can very easily reduce cognitive load and more importantly, speed up processing while maintaining all necessary granular information for closer analysis, final dispatch and audit protocols.

Custom Size, Colour & Design

Swab containers, biopsy pots, thin glass vials and in some cases, custom devices specialised for specific sample collections. Clinical trials can present a wide range of different substrates for labels to fit around. Quite often a standard square or rectangular label won’t do, creasing on curved edges, overlapping or simply not staying affixed.

Alongside all the features listed above, CILS specialise in creating durable laboratory labels in any shape, size, colour or design. Whether a small barcode is required on the cap of a vial or a large GHS warning label is required on the side of a round beaker of solvent, we can supply it. Whether you wish to print in house and simply require blank labels, or if you require all printing to be completed and ready for use, our team are here to help.

For digitised tracking or user QR/barcodes commonplace in clinical trials, our CILS 3.0 technology is also an extremely valuable piece of mind for many of our clinical laboratory clients. Our 3.0 print is capable of surviving 200 rubs of acetone, ensuring that our labels do not lose any quality in print, drastically decreasing the likelihood that sample information will not be legible by digital tracking systems.

What’s Next?

Selecting the right label from the above information may seem a little complex. This is why our laboratory label experts are on hand to help select the right label for you, give them your use case and leave the rest to us. Additionally, we can of course supply samples for your specific requirements no string attached, giving you the peace of mind you need that your labels will work before you roll them out across your trial.

Next time you are looking for clinical trial labelling solutions, trust the experts.

Get in touch with one of our laboratory specialists today.