Packaging timelines for clinical trial materials are often challenging. Meeting tight deadlines is even harder when having to blind comparator product used in the trial. Clinical trial sponsors that source their own comparator product aren’t always aware of the detailed requirements associated with blinding the material. If using an outsourced packaging provider, it isn’t unusual that the first time the provider sees the comparator product is after it has been sourced and delivered. This puts the provider at a significant disadvantage as the design process can’t start until they have the material in hand.
Significant advantages are gained by using alternate strategies to streamline the design and packaging process.
- Consolidate Services & Providers: Comparator sourcing, label production and packaging could be managed by three different organizations. Consolidating these to a single source provider has tremendous advantages. If your packaging provider is able to source the comparator product, they gain access to critical details much earlier in the process. This is especially true if they have extensive experience working with a large network of suppliers. Samples can be received, as can technical drawings and artwork which allows label and package design processes to begin.
- Work in Parallel: By reviewing technical drawings, artwork and (ideally) samples for both the primary and secondary packaging as soon as the comparator product has been purchased (vs. delivered), label size can be established. As soon as master label text is available, label design can start because placement and size are already established. With detailed specifications in hand it enables a proactive approach to packaging design. For example, it’s often necessary to apply a label to the primary container. If a thick booklet label needs to be applied to a vial it might not fit into the commercial carton. This allows early determination if a blank, standard carton might be a viable alternative. If the commercial carton is mandated, it may require creating two supplies with two slimmer booklet labels, each covering half the countries. There is a clear advantage to identifying that need up front and design the process accordingly.
- Mitigate Regulatory Delays: Europe requires Qualified Person (QP) release of all goods, which includes the need for a certificate of analysis (COA). This certificate isn’t always available for drugs manufactured in the United States. If that has not been proactively addressed it can introduce unexpected delays. By working with an organization that has extensive global comparator sourcing experience, they can proactively address this by seeking alternate sources that have the required certificate. Depending on their internal capabilities, they might even be able to use internal qualified laboratories to complete the analysis and issue the required COA.
My advice to clinical trial sponsors, especially those with more limited experience, is to begin the planning process as soon as possible. There are clear advantages gained by simplifying the supply chain. Engage the services of industry experts. Consolidating services such as comparator sourcing, label production, packaging and distribution allows activities to take place in parallel. This approach translates to tangible timeline advantages, and provides the greatest control to ensure all materials are ready on time and at the right place for patient visits.
In a recent study that required comparator product, the master label text regulatory approval process introduced an unexpected six-week delay. Label design, production and packaging had to be expedited to make up for lost time in order to meet critical first patient visit dates. Learn how a flexible approach with a focus on streamlined processes enabled the team to deliver within days vs. weeks.