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    International Clinical Trial Shipments Clearing Customs
    Ancillary Trial Supplies and EquipmentBusiness Insights

    Clinical Trial Logistics: Here’s How to Clear Customs

    by Dan Polkowski May 1, 2019
    written by Dan Polkowski

    Updated: July 11, 2022

    An important member of your study team is a person you might never meet! It’s your registered importer, known formally as the importer of record (IOR).

    When shipping study materials or medical equipment internationally, it is not unusual for them to get delayed in customs. In global logistics, the top two reasons imports are stopped by country customs are:

    1. Insufficient international paperwork

    2. The IOR supported by the pharmaceutical company or contract research organization client is not recognized as a registered importer by the in-country customs agency

    Why is your international clinical trial shipment in customs hold?

    Many in the clinical study global logistics process find their study materials placed in customs clearance hold because the party on the courier air waybill and pro forma invoice is not an in-country registered IOR. When this happens, customs agencies will place the import in a non-compliant status. That is typically when clinical study teams turn the IOR status into a reactive process. This creates delays and inefficiency for all involved in the study. A proactive process is key for customs clearance and delivery.

    The registered IOR in-country provides a critical role in global clinical trial logistics success. Be proactive in your selection. Secure and vet a knowledgeable and resourceful IOR in each country months in advance of your actual export date. That’s how to eliminate customs clearance mayhem.

    Requirements for IORs

    Your IOR needs to be compliant with the country’s import regulations, requirements, and processes exclusively when importing various medical ancillary supplies, electronics, and medical devices.

    He or she needs to be able to translate the clearance documents when requested by country customs, assist with formal clearance entry, and apply for licensure specific to commodities controlled by the country government Ministry of Health, Ministry of Commerce, FDA, or Consumer Product Safety Commission. 

    Get everyone on the same page

    From the very beginning of study planning to delivery in-country, open communication with all involved parties — pharmaceutical and contract research organization, exporter, courier, freight forwarder, importer, importer broker, and country customs — increases the outcome for optimum clearance and delivery.

    Proactive global logistics planning in advance of shipping takes time, and this approach may seem like extra work. However, it is a much better option than having your trial supplies held by country import customs for days, weeks, and possibly months.

    If you have questions about smoothing out the clinical trial logistics process feel free to let us know. We’re happy to help.

    For more global logistics information, check out our blog on the clinical trial supply chain.

    May 1, 2019 0 comment
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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    7 Questions to Ask Your Ancillary Supplies Vendor

    by Hope Cullen June 26, 2017
    by Hope Cullen June 26, 2017

    It’s common for sponsors and CROs to work with vendors to acquire ancillary supplies and ship them to sites. From the outset, it is important to fully understand your vendor’s capabilities and range of services to make sure you can attain your goals. Asking the…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    Ordering Study Supplies? Do You Need to Consider the Sunshine Act?

    by Hope Cullen June 19, 2017
    by Hope Cullen June 19, 2017

      We have found that many studies neglect to have plans in place regarding the Sunshine Act. Don’t overlook this! Sunshine Act reporting is required in clinical studies, and it should be included in planning your activities to ensure reporting compliance. The Sunshine Act, specifically…

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  • Site Materials & Logistics

    5 Countries with Challenging Import Regulations

    by Dan Polkowski March 14, 2017
    by Dan Polkowski March 14, 2017

      Shipping Study Supplies Internationally: How to Avoid Customs Delays in these Five Challenging Countries Shipping study supplies internationally is a challenge, even for the experts.  I have found In my 20+ years of global logistics experience that the shipping requirements of five countries consistently…

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Imperial Clinical Research Services Blog

Imperial is a global leader in clinical trial solutions and support, specializing in study and site print materials, ancillary trial supplies and equipment, clinical trial translation management, and clinical trial patient engagement.

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