Innovative six-part clinical trial label safeguards traceability

Innovative six-part clinical trial label safeguards traceability

‘Clinical trial labels have to be expertly manufactured with very close attention to detail. Even small inconsistencies in labelling material can prejudice the process. Special manufacturing conditions, sign off procedures and verification processes are paramount to give peace of mind and trusted results every time’.   

Clinical Trial 6 part label


Our customer runs a special unit within a large NHS Trust hospital. They are responsible for manufacturing and packaging drugs, as well as running clinical trials.

We have supplied plain, pharmaceutical grade, labels to the hospital unit for many years; becoming a trusted partner.  When our customer had a complex clinical trial labelling challenge, they came to Piroto for advice as they knew we had experience in this specialist area.


Traceability, that is connecting the right patient data to the right medication, is of paramount importance in clinical trials. A simple mismatch of data or loss of traceability can invalidate the results of a clinical trial and jeopardise months, sometimes years, of work. Our customer therefore needed to find a labelling solution for their trial that was 100% effective.

The trial involved labelling two different doses of the drug on trial, plus a placebo version. Our customer needed a customised traceability label that could accurately match patient records, data collection sheets and drugs throughout multiple stages of the clinical trial.


Having talked through the entire clinical trial process with our customer, it was ascertained that the following elements needed to be built into the label:

  • Fixed pre-printed data for batch number and expiry date
  • Variable pre-printed data for item numbers
  • Write-on section for patient study number and revised expiry date
  • Customised, die cut labels to accommodate the drug dispenser
  • Multiple identical labels to cater for secondary and primary packaging, plus the manufacturer’s log
  • Easy hand application.

Since the label specification was complex, the specially shaped label for the drug dispenser was mocked up to ensure the customer was happy with the size and fit prior to agreeing manufacture.


We developed a six part self-adhesive label. It incorporated three identical labels for the manufacturer’s log and primary and secondary packaging, two die cut pack labels for the drug dispenser and a patient record label. The label set was manufactured from a machine coated material. It had a craft liner to give the individual labels extra rigidity and ensure that they remained curl-free and easy to apply.

The six part label sets were presented on a roll, each set was separated with a perforation.  To guarantee the label sets could be removed easily, the perforations were designed to start and end with a cut, this allowed easy handling and application.

Each edition, consisting of two different doses and a placebo, went through a careful sign off procedure during manufacture, using a specific check list approved by our customer. Roll end seals bearing the batch number, spec number, roll number, roll quantity and customer reference number were printed and applied to each label roll.


Thanks to the experience that the Piroto team have in traceability labelling in general, and clinical trial labelling in particular, our customer received customised labels to meet their needs perfectly. Specific benefits include:

  • An innovative customised labelling solution that delivered exactly what was required to ensure full traceability and validity of the clinical trial
  • Peace of mind that best practice for clinical trial label manufacture had been followed throughout the process to safeguard the trial in line with our customer’s expectations
  • Attention to detail, which meant that the labels were easy to apply.