Why is an importer of record (IOR) essential in the clinical trial supply chain?

If you are tasked with managing important clinical trials, you may encounter the need to use investigational medicinal products (IMPs) made in foreign countries. Importing these medicines and distributing the supplies is a complex process that requires meeting regulatory requirements. Therefore, the importer of record (IOR) plays a key role.

You may be surprised at how many steps the IOR is involved with in the clinical trial supply chain. The IOR responsibilities can include:

  1. Customs Compliance: Instead of being forced to navigate a mountain of paperwork and regulations standing between your clinical trial materials and their designated country, the IOR can be hired to act as your voice and manage customs documentation, duties, and taxes, ensuring every requirement is met with precision.
  2. Regulatory Compliance: Each country has its own unique set of regulations for importing IMPs. Trying to navigate this on your own requires extensive research and time. The IOR will already be familiar with regulatory requirements for importing and distributing IMPs in each country involved in the clinical trial. The IOR knows who needs to be contacted and will be the one responsible for ensuring a seamless import.
  3. Quality Assurance: The worst nightmare for your clinical trial would be if any of the supplies being handled are compromised while getting imported and are unable to be used. To prevent this, the IOR will make sure that all transportation and distribution processes are done safely and within the required temperature range. The IOR is there to monitor your shipment while you put your energy into your clinical trial.
  4. Logistics and Distribution: Coordinating international import, storage, and distribution can be daunting if you are going at it on your own. Keeping a tight line of communication is what the IOR does best. The IOR’s specialty is collaborating with logistics providers to ensure your supplies reach their destinations timely and securely. Their job is to make sure there are no delays and vital materials are not missing in a shipment.
  5. Risk Management: Even before the process of importing your IMPs begins, the IOR can work up a game plan to ensure that everything goes smoothly. Because they have the importing experience, they can easily identify and manage potential risks associated with the importation and distribution of your clinical trial supplies. You’ll have a full understanding up front of any potential delays or compliance issues you may face, giving you time to reduce surprises and plan ahead.

Running a successful clinical trial means setting yourself up for success. Partnering with an IOR isn’t just an option, it’s an essential investment in the success of your clinical trial. They bridge the gap between complex international regulations and your research goals, streamlining a potentially burdensome process into a smooth and efficient operation. Don’t let international border challenges hinder your vital research – use an IOR, and unlock the full potential of your clinical trial journey. At Bay Area Research Logistics, we can help with all aspects of clinical trial logistics, including planning, packaging, labelling, storage, distribution and acting as an IOR.

Reach out to us to learn more about how we can support a seamless import of your clinical supplies. We’re happy to answer any questions and tailor our services to your specific needs.

66 Innovation Drive
Dundas, ON, L9H 7P3
905-521-2248

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