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Clinical Trial Materials

    Clinical Trial Business Insights

    7 Caveats to ‘Just Ship It’, Part 1

    by Dan Polkowski June 1, 2017
    written by Dan Polkowski

    If you think logistics isn’t your business, think again…

    I often hear the phrase: “I provided you an address, just ship it, what’s the big deal?”

    Logistics processes are not just for logistics personnel – they should be understood by everyone involved in the process in order to avoid thousands of dollars in delays and fines. Here’s my quick take on how to keep your materials on schedule.

    My 7 caveats refer to key pieces of information that everyone involved in the process should be aware of – 7 pieces of the global logistics puzzle that can result in hefty delays and fines if overlooked. In this blog post, I’ll dive into the first few.

    1. Declared Value: the manufacture cost or invoice amount charged to the client, i.e. what one paid to have the goods produced.

    ​There are times we are asked to undervalue the clinical printed material or classify it as mail correspondence or documents and to declare a nominal or zero value to the shipment. They may also ask us to report a lower value in order to expedite or simplify informal or formal clearance processes conducted by customs authorities. However, we must accurately report values according to regulations.

    Criminal penalties can lead to 20 years in prison, up to $1 million per violation, and loss of export privileges.”

    In cases where materials are devalued, governments have the ability to issue regulations regarding impositions of civil and criminal penalties for violation of declared value requirements. Civil penalties refer to monetary fines. Criminal penalties can lead to 20 years in prison, up to $1 million per violation, and loss of export privileges.

    2. Role of the Consignee: the Consignee must be registered with Country Customs as an importer.

    The Consignee is a party named by the owner of goods in transportation documents as the party to whose consignment will be delivered at the final delivery location in-country. The consignee is considered to be the owner of the consignment for the purpose of filling the customs declaration, and for paying duties and taxes if it is their responsibility to pay.

    It is critical when shipping Clinical Study Materials to another country that recipient (consignee) is registered with country customs as an importer. If consignee is not registered importer, shipment is placed in customs clearance delay until a proper importer is assigned – this could take a few days at minimum, resulting in significant delays.

    3. Importer of Record: responsible for assisting clearance of shipments by verifying important information.

    Importer is responsible for assisting clearance of shipment with assigned carrier. Importer is responsible to verify name of consignee, product, value, terms, translation, and reason goods will be used for, broker to use, etc. Importers broker over rides shipper’s broker. If one of these pieces of information is not provided or verified within a specific time period, shipment is placed in customs clearance delay until the requirements are met. Alternatively, the goods may be returned back to shipper at their expense.

    Click here for Part 2, which dives into the rest of the 7 caveats

    If you have any questions, I’d love to hear from you at DPolkowski@imperialcrs.com

    June 1, 2017 0 comments
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  • Clinical Trial Business Insights

    2 Tips for Shipping Your Clinical Supplies Internationally

    by Dan Polkowski May 15, 2017
    by Dan Polkowski May 15, 2017

    Shipping clinical study supplies internationally is an art and a science. Customs departments add an unsympathetic layer of bureaucracy – if paperwork and preparations aren’t in line with the country’s regulations, you can expect headaches that will add costly delays that could impact your study’s …

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  • Clinical Trial Business InsightsClinical Trial Materials Development and Printing

    Reclaiming the Power of Paper for Clinical Trial Materials

    by Hope Cullen June 15, 2015
    by Hope Cullen June 15, 2015

    We live in a digital world.  Need directions? Use your phone app. Looking for your bank balance? Simply open your mobile banking app and log in. Want to read a book? Just download it! Paper printed materials are becoming a thing of the past. I’m …

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  • Clinical Trial Materials Development and Printing

    Developing High-Quality Printed Materials for Clinical Trials

    by Hope Cullen February 10, 2014
    by Hope Cullen February 10, 2014

    There are three major categories of printed materials supporting clinical trials: 1) Recruitment and Retention Tools, 2) Data Collection Tools and 3) Site Reference Tools. Why differentiate? Because the intended use of the tools, the time, money and quality put into the development and print of …

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  • Clinical Trial Business Insights

    Things to Consider When Shipping Internationally

    by Hope Cullen October 3, 2013
    by Hope Cullen October 3, 2013

    As industry professionals, we spend a lot of time and energy writing, designing and producing materials in support of clinical trials. During this process, shipping materials to their final destination is often an afterthought, with address information provided at the last minute. This is not …

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