Late-stage clinical trials are commonly carried out at multiple research centres, often across several different countries, and sovereign and regulatory jurisdictions. In the search for suitable patients who are treatment-naive, pharmaceutical companies and clinical research organisations (CROs) are increasingly looking to countries where there are relatively untapped sources of subjects, so there has been significant growth in the number of studies taking place in the Middle East, Africa and Eastern Europe.
Clearly, this introduces significant logistical challenges into the clinical supply chain, with materials having to be shipped to different places where the customs requirements can be very difficult. Customs officers often do not understand the products, their requirements and, crucially, the difference between marketed pharmaceutical products and clinical supplies.
The first step is to know the importer and whether they are the import-licence holder themselves. In some instances, the licence holder is not the same as the importer, and the two must work together to ensure a smooth passage through customs.
Getting the documentation in order is important, too, including an accurate value declaration. Although certificates of analysis are generally not required, it is advisable to include them, particularly when entering a new market. Sending the documents ahead of time to ensure that customs will be satisfied with them is a good way to reduce the risk of a shipment being held up for days. Supplies must reach the trial sites in usable condition and arrive on time. Particularly with a temperature-sensitive, high-value investigational medicinal product, avoiding unnecessary delays is critical to maintaining the integrity of the product.
Culture clash
There is another challenge that is often overlooked: the differences in cultures between countries. The most obvious one is the language barrier – a particular challenge in parts of the Middle East and Africa, for example. It is important to communicate carefully when there is a language difference. In conversation with people at clinical sites, repeat what you understand back to them, and have them do the same to you.
Video calls are preferable to voice calls. Even better is a face-to-face meeting in person, as this will confer respect and facilitate communication. However, it is not a substitute for having a good network of people who are treated as partners on the ground. They will have invaluable local knowledge, including a deeper understanding of more subtle potential cultural pitfalls. The thumbs-up sign, for example, is a commonplace shorthand for ‘yes’ or liking something in much of the western world, yet, in Arabic countries, the sign is considered an insult. Similarly, the ‘OK’ hand signal can be mistaken as offensive in parts of Europe and South America.
The etiquette surrounding personal interactions and meetings varies around the world. In hierarchical Asian societies, introductions should begin with the most senior person in the group first and then work down the levels of seniority; and, while many cultures may include personal conversation within a business meeting environment, some are far more direct and work strictly to an agenda. Having local assistance can help in complex situations where a client may be reserved or where an answer may be misinterpreted.
Getting the business culture right is essential for ensuring effective communication over the complex and detailed logistics of trials supplies. It can be invaluable to engage local partners to seek advice on how the local regulations and laws relate to those elsewhere. The use of experienced international couriers and customs brokers, including at a local level, can ensure the appropriate handling of products throughout the shipment. Cultural understanding and careful communication are key to smoothing out the complexities of cross-border clinical trials logistics.
