Global capabilities: the key questions to ask your equipment supplier before your next clinical trial

The clinical trials landscape is rapidly evolving. In previous years, most of the world’s trials were conducted in mature markets like North America and western Europe. But today, as medical capabilities advance around the world, increasing numbers of trials are now routinely staged in eastern Europe, Latin America, Asia Pacific, MENA, and sub-Saharan Africa*.

For CROs and sponsors, these emerging territories provide greater patient diversity and create opportunities to reach a wider patient population, especially when combined with the unprecedented reach of decentralised trials. They often provide access to huge numbers of eligible participants, while also giving the patients access to new medication.

However, there are still several challenges to navigate, especially around local knowledge, infrastructure (reliable airports, cargo offerings, and couriers), importing, and varying regulatory frameworks.

Understanding the challenges in clinical trial logistics

As clinical trials spread into traditionally hard-to-reach areas, clinical trial suppliers need to invest in a range of logistics capabilities. As someone responsible for the successful delivery of your clinical trial, ask your supplier:

• What is your level of regulatory understanding in each territory?
• Do you have global Importer of Record capabilities?
• Have you invested in developing a network of global depots?

Global logistics is undoubtedly a complex area, but errors can quickly escalate and lead to significant negative consequences. If a supplier of laboratory equipment and devices makes just one mistake, imports can be blocked at Customs. This prevents products reaching the trial participants, and subsequently leads to increased participant drop-out rates. With recruitment often the most challenging part of a trial, maintaining participation levels is key.

Import licences can also be a significant issue. Import licence applicants (those aiming to become an Importer of Record) must be registered with the local regulatory body. Manufacturers and distributors will normally only deliver products to facilities registered with import licence holders, so having access to a depot that can act as an Importer of Record is essential. Our depot locations – including Singapore, Japan, Mexico, and Kenya – are strategically positioned to provide coverage across LATAM, North America, MENA, Asia Pacific, and sub-Saharan Africa.

Of course, there are instances where depots might not be necessary. Depending on the volume of product being imported, it could be delivered straight to the clinical site. But your suppliers will still need to have the knowledge and capability to work with appropriate local courier companies and Importer of Record services to get the best possible routing. Securing the most efficient plan or process helps to ensure trials meet their deadlines.

We work with partners around the world to offer Importer of Record services in an extensive number of key international markets, including Singapore, Brazil, India, Saudi Arabia, Canada, Argentina, and South Africa.

Two quick checks for your next clinical trial suppliers

Before working with a new supplier, it’s worth conducting two quick checks.

First, ask colleagues or other industry peers if they know of any reputational issues. Suppliers that cannot deliver what they promise can risk the timetable and, in extreme cases, the entire viability of a potential clinical trial.

Second, don’t be afraid to take time to test their knowledge. Challenge your potential supplier with questions about global logistics, warehousing, importing, and regulatory frameworks.

In fact, why not start by asking us your questions about anything to do with supply logistics? We’ll be happy to help. Contact us today.

_{Reference:
* https://www.clinicaltrialsarena.com/sponsored/how-to-navigate-changes-in-the-global-clinical-trial-map/}