Designing the packaging and labeling for investigational new drugs (INDs) and investigational medicinal products (IMPs) can be a complex task — especially when you need to balance timelines and quantities with patient experience.
Here, we’ll dig into the following key considerations for clinical trial packaging and labeling:
Kit design and packaging considerations
A clinical trial kit may include the container(s) for the IND or IMP itself as well as instructions, sample collection materials, and/or tamper-proof seals — all examples of packaging.
Clinical trial packaging optimization is all about reducing waste and mitigating risk while also providing a positive patient experience. Here are a few things to consider:
Kit packaging
Part of the kit design process is determining which packaging materials are most appropriate for the drug or product being tested.
For example, an orally-administered drug may be packaged in a bottle or a blister pack, whereas an injectable medication may require vials, autoinjector pens, or pre-filled syringes. Some products require cold-chain shipping, advanced tracking, or extra packing materials to protect them from damage.
Kit size and distribution
The number of doses, products, or collection materials included in each kit — and how often kits are distributed to patients — is another important aspect of kit design.
It’s essential to consider both patient centricity and risk/cost mitigation in this category. For example, too many doses in one IND kit may lead to drug waste and overwhelm patients, while too few may increase distribution costs and/or require patients to make too many trips to the trial site.
There is no single kit design formula that works for all trials, so it’s necessary to test and plan for different scenarios. Software like the N-SIDE solutions can help your team determine the optimum kit size and distribution schedule based on inputs like expiry dates, visit schedules, trial length, and production/overage costs.
Scenario planning via the N-SIDE software helps facilitate collaboration between supply, packaging, manufacturing, and clinical teams. With this software, teams can work together to assess the quantified impact of kit design on the trial before it even begins — and continue to optimize as it progresses.
Testing kit designs with the N-SIDE helped EMD Serono achieve a 41% reduction in waste. Learn more.
Labeling considerations
Clinical trial labeling is the method by which labels provide specific information about the IND or IMP. This information may include, but is not limited to:
- Instructions
- Mode/route of drug administration
- Lot or batch number
- Dosage, concentration, and strength
- Expiration date
- Storage requirements
Clinical trial updates and modifications are frequent. Redesigning and reprinting labels each time a change occurs is costly and can lead to timeline and supply disruptions, and the products may expire in the meantime. Here are three things to keep in mind as you plan for labeling:
Regulations for globalized trials
Companies are increasingly conducting simultaneous clinical trials across multiple countries. Labeling regulations vary between countries, with different requirements for what must be included on the label.
Software can help manage labeling for multiple countries and ensure regulations are met across borders, even as requirements evolve.
Just-in-time labeling (JTL)
With JTL, products are labeled just before distribution rather than all at once. This can greatly reduce or eliminate the need to relabel kits and allow for greater flexibility, which cuts down on waste.
One example of a JTL strategy is bright stock, which refers to unlabelled but uniquely identified stock that is shipped to local depots for final packaging, and then sent to sites as needed. This approach is particularly useful when multiple trials utilize the same kit type, as each trial can draw from the same pool of kits, applying the corresponding label just before they’re sent out.
Expiry extensions
When expiry dates are extended, kits must be relabeled with the correct date. These changes impact supply — kits that were originally set to expire too soon to be utilized may become available, while relabeling may require shipping kits from depots back to a central manufacturing center.
The N-SIDE solutions can help trial managers account for expiry extensions during both the planning phase and the study itself. With N-SIDE, trial managers can estimate the impact of their stability plan with scenario planning, and then continue to optimize their labeling strategy as expiry dates change throughout the trial.
Conclusion
To maintain a positive patient experience, mitigate risk, and minimize waste, clinical trial teams need to make informed decisions about every aspect of their packaging and labeling throughout the trial process.
Clinical trial planning and optimization software like the N-SIDE solutions offers the end-to-end transparency and flexibility necessary for building an effective packaging and labeling strategy. With insights from the N-SIDE platform, your teams can collaborate to ensure that your packaging design, manufacturing plan, and distribution plan don’t just align, but continue to improve as the trial progresses.
Diogo Ribeiro
