An Importer of Record (IOR) plays a critical role in clinical trial logistics, acting as the legal entity responsible for ensuring that imported items, like investigational drugs and medical devices, meet all customs and regulatory requirements. IORs streamline international trade and compliance, enabling trial sponsors to concentrate on research while overseeing risk management and logistics.
IOR Process Ownership
The IOR can be different parties depending on the specific import transaction, the process owner is generally one of the following:
- The owner or buyer of the imported goods, holding a financial interest in the shipment
- The consignee, who receive the goods after they pass customs
- A customs broker or third-party logistics provider representing the importer (as KOR-PLUS)
In clinical trial logistics, the process owner is often the trial sponsor or a designated third-party service provider specializing in IOR services for medical research. KOR-PLUS can also assist with this service. We take temporary ownership of the imported clinical supplies during customs clearance, ensuring compliance with regulations and handling all documentation and financial responsibilities. By owning the IOR process, we streamline imports of investigational drugs, medical devices, and other trial materials while allowing sponsors to focus on research activities.
Role of Importer of Record
In clinical trials, IORs assume specialized roles tailored to the specific needs of medical research. With KOR-PLUS, we will take goods care of needed requirement on dossiers of the mentioned trial before importing to local country, such as import permit, professional licenses, testing certificate, etc. Our expertise includes:
- Managing temperature-sensitive shipments to preserve product efficacy
- Coordinating distribution across multiple clinical sites
- Ensuring investigational products are properly labeled and packaged
- Navigating country-specific import regulations for regulated commodities like medical devices, trial medicine, biological sample, etc.
Benefits of IOR in Logistics
Partnering with an IOR isn’t just an option, it’s an essential investment in the success of your clinical trial. If you have a partner of customs broker locally, you can only be support with advices and suggestions when facing local issue. But with IOR, you will have a whole compliant process, and we will deal with your problem, light weight your burden at local.
IOR | Customs broker | |
Legal Responsibility | Legal Compliance | Advisory role |
Financial Liability | Financial Responsibility:
| Limited Liability:
|
Engagement with Authorities | Direct interaction | Mediating Role |
Documentation | Oversight of dossiers. Prepare and carefully check before receive feedback of final version with client | Support base on client advise. |
Import process and Specialized Expertise | Comprehensive oversight of whole process. | Specialize guidance |
We 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. KOR-PLUS is here to support.