Packaging
Subject to requirements
Clinical trial materials each have unique packaging requirements, and there are also a number of processes and systems to consider that can help to minimise delays and ensure a swift delivery. Bruce Hastings, managing principal at De Mi Tierra Consulting and former director of process technology at Amgen, discusses with Lyn Eyb how packaging can optimise trial effi ciency.
he demands of clinical trials are many and varied. Detailed planning and execution are critical to achieving optimal research outcomes, and compiling key product and patient data. Every aspect of a trial – including packaging design and manufacture – needs to be meticulously orchestrated in order to ensure trial success. Packaging provides a unique challenge, one that is often neglected in terms of allocating the appropriate time, budget and logistical expertise required to safeguard the integrity of a trial.
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The design and manufacture of packaging for clinical research does not present the same aesthetic or regulatory hurdles as in the commercial environment. However, getting it right can make or break a trial – and have a significant knock-on effect on the commercialisation of a therapy. Study designs and trial protocols must consider practical, clear and user-friendly packaging that can be employed across multiple markets and study phases. Add cost implications of small-scale production, and the challenges of blind-testing and
Clinical Trials Insight /
www.worldpharmaceuticals.net
Pavel Kubarkov/
Shutterstock.com
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