Packaging and Labelling

Efficient quality-driven solutions
tailored to your project.

Whether you are running a Phase 1 trial for one individual or a global Phase 3 trial with thousands, we provide secondary packaging and labelling solutions to meet your needs. From our state-of-the-art facilities in Canada and the United States, we offer demand-led packaging, traditional booklet-label packaging or a hybrid model to ensure product waste is kept to a minimum without compromising patient access.

LABEL DESIGN AND PRINTING

Designing a label for a clinical trial can be complex. We make it easy for you.

Whether your trial is open-label or blinded, we have the regulatory experience, translation services and detail-oriented processes to help design a bespoke label that meets your requirements.

  • Country-specific language – We hold a database of commonly used country-specific text to meet regulatory compliance.
  • Blinded clinical trials – We can generate randomization lists from which kit numbers on the clinical trial label can be pulled.
  • In-house printing – We provide in-house printing of single-panel labels and can design and over-print booklet labels for global trials.
  • Attention to detail – We consider all the detail, such as the product temperature and source labels that adhere to surfaces at a range of temperatures.

PACKAGING DESIGN AND EXECUTION

A successful clinical trial supply chain requires a flexible packaging partner.

As clinical trials become more complex and adaptive, ensuring minimal impact on the supply chain is imperative. We offer multiple packaging solutions that deliver efficiencies in speed and waste reduction while minimizing the burden on patients.

  • Customized solutions – We customize packaging depending on the complexity of the trial, such as whether the trial is blinded, or whether medicines are temperature-controlled or taken home by the patient.
  • Expedited packaging and labelling – We can set up, pack and release material in as little as five days for new projects and two days for repeat packaging runs.
  • Flexible supply – To maintain flexibility we offer standard packaging runs, demand-led supply or a hybrid of the two.

Traditional Model

Benefits:

  • Reduces component cost
  • Offers flexibility to use the stock across multiple countries
  • Fewer packaging runs

Considerations:

  • Often an increased amount of drug waste
  • Shelf-life extension could be required

Packaging and Label Design

Packaging and Labelling

Quality Release

Product Stored

Product Ordered

Distributed

Demand-led Model

Benefits:

  • Can apply the expiry date at the point of order
  • Reduces likelihood of a shelf-life extension
  • Preserves drug until it is needed

Considerations:

  • Can lead to multiple packaging runs with a heavy QP involvement (in Europe)
  • Will not work for all protocol designs

Unlabelled Product Ready for Packaging

Storage at RxSource

Product Ordered

Packaging and Labelling

Quality Release

Distributed

Quality and IxRS release

Once the packaging and labelling activities are complete RxSource will quality review, and if acceptable, release the material for clinical trial use. Our quality review ensures that all procedures are followed, the temperature range is maintained, and kits are blinded as appropriate.

Once released by quality review, we will upload blinded kit numbers into your IxR system, if required. We liaise closely with your IxRS team to understand how orders will be received and if possible, automate the process with our internal systems. We are also happy to recommend IxR systems based on our experiences.