Will it get there? Seven questions to ask your equipment supplier before your trial goes global

A global trial can have a brilliant protocol, motivated sites and a strong recruitment plan, and still stall because an analyser is sitting in a customs shed on the wrong side of a border. When equipment doesn't arrive, sites can't open, patients can't be screened and timelines start to slip.

Most suppliers will tell you they offer global delivery. The difference between the ones who mean it and the ones who don't usually shows up in the detail. That's where the right questions help.

The questions below are worth asking whether you're writing the protocol, vetting suppliers in procurement or running a site that needs everything ready on day one. For each one, we've included what a good answer should sound like.

1. Which countries have you actually delivered to recently?

"Global reach" is easy to claim. Recent, real deliveries are harder to fake. Ask which countries a supplier has shipped clinical trial equipment to over the last few years, and whether that includes the countries on your study list.

A good answer: a list of real countries, with dates. If a supplier can only tell you where they could deliver in theory, treat that with some caution.

To give you our own answer: over the last three years, Woodley Trial Solutions has supplied equipment to 82 countries worldwide, and we offer Importer and Exporter of Record services in more than 120.

2. How do you check equipment can be used legally in each country before it ships?

A device that's approved in the UK or US isn't automatically cleared for use everywhere else. Different countries have different rules for medical devices and diagnostics, and some have their own registration requirements on top. Practical details matter too, such as power supplies, plug types and the language on labels and instructions.

A good answer: the supplier checks regulatory status for every country on your list early, ideally while the protocol is still being written, and tells you about any problems before equipment has been ordered. They should know the main frameworks, such as EU MDR and IVDR in Europe and FDA requirements in the US, and know where to look for everything else.

3. Who handles customs, including in harder-to-reach countries?

Someone has to be legally responsible for importing equipment into each country and, at the end of the study, exporting it again. That's the Importer of Record (IoR) and Exporter of Record (EoR). If that responsibility isn't clear, shipments get held and sites end up chasing paperwork they shouldn't have to deal with.

Some countries are more demanding than others. Extra permits, longer clearance times, inspections and remote delivery locations all add risk.

A good answer: the supplier acts as IoR and EoR themselves, or manages it fully on your behalf, so sites don't need to get involved. For more complex countries, they should be able to explain how they prepare permits and documentation in advance, which local partners they work with and how long clearance realistically takes, so it's built into the plan.

4. How do you handle temperature-controlled shipments?

Reagents, test cartridges and some devices need to stay within a set temperature range from the warehouse to the site. One excursion can make a whole shipment unusable, and you may not find out until someone tries to use it.

A good answer: validated packaging chosen for the route and the season, temperature monitoring throughout the journey, and routing through facilities that can store goods at the right temperature if there's a delay. Ask what happens if an excursion is recorded, and who decides whether the goods can still be used.

5. How will you make sure everything is at site before the initiation visit?

The site initiation visit (SIV) is a fixed date with a lot of people working towards it. If equipment arrives late or incomplete, the visit gets rescheduled and the site opens late.

A good answer: the supplier plans backwards from your SIV dates, allowing for customs and transit time in each country, and gives you tracking so you're never guessing. It's also worth asking about the last few metres. A good supplier can arrange delivery to the right building and department, unboxing and scheduled delivery times, so equipment doesn't sit in a hospital loading bay.

6. What happens if equipment fails or goes missing mid-study?

Even good equipment breaks down now and then, and the odd shipment goes astray. When it happens, the site needs to be back up and running fast.

A good answer: spare stock held in regional warehouses close to your sites, a clear process for replacement shipments and technical support that can help diagnose the problem quickly. Ask how long a replacement would take to reach your most remote site, not just your nearest one.

7. What happens to the equipment when the study ends?

Close-out is easy to overlook at the planning stage. Rented equipment has to be collected, exported and accounted for, and that can be just as complicated as getting it there in the first place.

A good answer: the supplier plans returns from the start, handles the export paperwork and collects equipment from every site, with a record of each item. You shouldn't be left chasing devices from sites months after the last patient visit.

Getting your equipment where it needs to be

Global logistics rarely gets the attention protocol design does, but it's often what decides whether a trial starts on time. Asking these questions early, before contracts are signed and SIV dates are set, will tell you a lot about whether a supplier can deliver what they promise.

Woodley Trial Solutions has spent more than 35 years supplying equipment to clinical trials. In the last three years alone we've delivered to 82 countries, supported by IoR and EoR services in more than 120, warehouses in the UK, US and Netherlands, and temperature-controlled shipping that's tracked all the way to site.

Need reliable global logistics for your clinical trial? Find out more about how we can support you and challenge us with your questions here.