What your Clinical Study Design Reveals About your Clinical Packaging Needs

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As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Today’s sponsors must be able to manage and coordinate multiple resources, processes, and locations with speed and accuracy to design effective and efficient clinical trials. Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success.

To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. These details encompass the intricacies of logistics, distribution, staffing, patient recruitment, patient adherence to therapy, and regulatory compliance. By engaging an agile partner with the ability to identify the best supply strategy for packaging and shipping your product, a sponsor can avoid costly interruptions to its clinical supply chain. A competent partner should also be able to set a reliable plan in motion that successfully manages material readiness throughout the duration of clinical testing. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.

“If a sponsor waits too long to engage a packager, the packaging options can become limited due to time, which could negatively impact the patient/user experience.”

Engaging a clinical packager early provides you with a trusted resource that can help you think through some of the challenges of planning and designing a study; it can also advise you during any unexpected obstacles that can often arise during a clinical trial. One detail of a clinical packaging strategy is specific information to determine how the drug products in a trial should be distributed to a sponsor’s various sites. While these details are not always immediately available, you should not wait until you have them before contacting a clinical packaging partner.

In addition, if a sponsor waits too long to engage a packager, the packaging options can become limited due to time, which could negatively impact the patient/user experience. For example, in a scenario where a clinical trial has a complicated dosing plan, a wallet with blister strips can help patients remember how and when to take their medication. Preparing the drug in blister packs takes time though, so the later study size information and dosing instructions are provided to a partner, the more difficult it is to use this packaging option. An alternative to blister packs is bottles. In studies where dosing size and frequency can change regularly, the right packaging can be the difference between patient compliance and noncompliance.

These are just a few reasons why early engagement is vital and why it is necessary to have a knowledgeable partner. With proper and early planning, it can help anticipate and overcome challenges that could derail your clinical program and potentially the commercialization timeline.