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International Clinical Trials

Tools of the Trade


As electronic equipment plays an increasingly important role in clinical trials, hardware shipping requirements must be taken into consideration. Local knowledge is vital to ensuring that the devices arrive on time. Increasing the use of technology within the clinical research field requires additional logistical organisation and consideration of a number of factors during study start-up. As the need to ship computer hardware and technology equipment to research sites across the globe grows, it is imperative to apply lessons learned from past experience to avoid unnecessary delays when initiating sites for new projects.

Hardware is a critical component of a project and must be delivered before sites can begin important trial activities. Missing key stages on a trial’s timeline could translate to costly delays, which threatens the all-important first-in-patient milestone. To avoid jeopardising the study, it is crucial that the project team understand the potential complexities they may face with delivery of the hardware to site. Necessary hardware includes laptops, smart phones, cameras and audio recorders. If a sponsor or vendor is new to shipping overseas, it’s important to create a database that not only closely tracks shipping intelligence metrics, but that also creates a system for tracking positive and negative experiences. This information will be utilised on future projects and referred to at the beginning of each one.

During project planning, details of shipping requirements for each country need to be considered as early as possible. All timelines for projects need to take relevant shipping times (per country) into account, which often involves close communication and co-operation with the client to ensure specifications and arrival times will be met.

Case Study: Russia

The shipment of eight laptops to four sites within Russia over a 12-week period from the UK proved to be the most demanding of the project’s requirements. The initial shipment of two laptops to one site within Russia provided insight into the challenges faced when shipping electronic equipment to Russia. Although the laptops were sent three weeks prior to site initiation visit (SIV), they did not arrive at the site until four days after the scheduled SIV date.

Preparation prior to shipping included direct communication with the usual global courier, and import documentation was completed as advised by the courier and accompanied the laptops. Difficulties encountered in shipping to Russia included:

  • Delays in notification of customs problems
  • The lack of a local courier agent at destination airport, which delayed specific details of the problem being communicated back to the sender
  • A lack of clear information as to the reason why the shipment had been held in customs
  • A lack of clear corrective actions to be taken by the sender to ensure customs clearance

After multiple conversations and a two-week hold on the hardware, it was communicated that the shipment was lacking several key documents, namely a Declaration of Conformity of the laptops and technical specification information from the manufacturers. This information had not been required for any other country and the need for such information was not readily available from the courier. The result was that the laptops were returned to the UK, as they did not appear on a list of ‘acceptable’ makes of laptops allowed to be imported into Russia. It was necessary to purchase the acceptable laptops, prepare each laptop with the correct configurations, perform quality control procedures, collate all necessary documentation and finally re-ship to the site. The result of the initial delay was a push back of five working days for the SIV of the site. The remaining sites benefited from the lessons learned, which enabled timely delivery of laptops for the rest of the project.

Case Study: China

China has strict customs restrictions and failure to follow them can lead to extended time in their customs office and often the return of the commodity to the sender. These restrictions include import licenses as well as documentation of the device that is being sent.

Shipping requirements for China – in particular, the time required to obtain the necessary licenses and documentation – are daunting and can lead to a loss of participants enrolled in a project. This process is particularly challenging when a client/sponsor requires devices to be sent to China without having the licences and documentation in place.

In this case, a client insisted that the devices should be sent, despite the fact that the paperwork was not in place. Although the client was advised otherwise, the devices were shipped as instructed. All of the devices were stopped in customs and neither the client nor our team was able to get them through. The devices were held for four months and then returned to sender.

During this time, a different solution was found. Because Hong Kong has much more lenient importation requirements than other cities in China, the devices were sent to Hong Kong and a courier was arranged to deliver them to the various destinations in China.

This approach was a success and allowed the importation of the devices to occur in a timely manner, and many of the complications seen in the past were bypassed.


Shipping Hardware Internationally: Useful Tips and Considerations

The origin and destination of a shipment are of equal importance. When shipping to a ‘new’ destination, use couriers with a good track record and local offices in the destination country, and sometimes purchasing and configuring hardware ‘in country’ can be a useful time-saver in challenging destination countries. It is also useful to establish a global network of local IT support that can expedite and address issues as they occur.

The ability to track the progress of shipment online gives peace of mind. Consideration of the import restrictions and regulations (pro forma invoices, commercial invoices, import licenses and technical documents) is essential – if not properly addressed, these can cause unnecessary delays. Remember that specific documentation requirements can change with little or no warning. Local staff – be it a courier with a local office or the assistance of the client’s local CRA – can help to ensure the latest import requirements are being met. Most originating countries require tax identification codes to be present on the shipping documents before they will allow the goods out of the country. The customs value declared on the invoice, if too high, can cause additional delays in customs.

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Karen Harley is the European Regional Manager with Bracket providing training, data quality, IxRS, ePRO, computerised cognitive function testing and consulting services to the pharmaceutical industry. Karen has over 17 years of experience in the clinical research industry. Prior to Bracket, Karen led a team of science graduates providing a variety of services to the pharmaceutical industry including TMF remediation and monitoring services. For 16 years, Karen was head of a 30-bedded Phase 1 unit based in Slough, UK. Karen is a Registered General Nurse with a BSc Degree in Nursing.

Christopher Nightingale graduated from the University of Brigham Young with a double major in Linguistics and Spanish. He has over 10 years of experience in the IT field performing duties as a web developer, database manager, network administrator, computer technician and graphic designer. He started working for Arrowhead Electronic Healthcare in 2008 and advanced to the position of Manager of their Logistics and Procurement department. Christopher is currently studying Speech Language Pathology at the University of Texas, Austin.

Karen Harley
Christopher Nightingale
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