Importer of Record (IOR) Services for the Smooth Running of Clinical Trials
Running a clinical trial can be a complex process, particularly when it spans multiple countries. Among the many crucial components that ensure the seamless execution of a trial, the role of Importer of Record (IOR) can sometimes pass unnoticed. However, an IOR plays a pivotal role in ensuring the smooth running and success of a clinical trial.
In this insight, we look at what an Importer of Record is, the requirements of an IOR and the key responsibilities.
What is in Importer of record
An Importer of Record, or IOR, is an entity or individual responsible for ensuring that goods imported into a country, comply with local customs and regulatory requirements. In the context of clinical trials, the IOR takes on the responsibility of managing the importation of investigational products, medical devices or equipment required for that trial. They act as a bridge between the trial sponsors, logistic providers and relevant regulatory authorities. Their expertise in navigating regulatory complexities and customs procedures is essential.
What are the requirements of an Importer of Record
- Legal Entity: The IOR must be a legally registered entity within the country where the trial is taking place. This is essential to facilitate compliance with local laws and regulations.
- Expertise: An IOR will need to possess the relevant knowledge and expertise of regulatory matters customs procedures in order to navigate the clinical trial logistics effectively.
- Local Representation: The Importer of Record should have a local presence or suitable network of contacts to meet the needs of the trial. These would include relationships with local customs authorities, government agencies and logistic providers.
The responsibilities of an IOR can vary subject to the demands of the trial. However, primary duties undertaken include:
- Regulatory Compliance: ensuring that all imported materials and equipment meet the standards and requirements of the importing country.
- Customs Documentation & Duty and Tax Management: the preparation and submission of customs documentation such as import permits and licences. In some instances, Importer of Records may need to secure customs bonds to facilitate the importation of goods and equipment. This ensures that financial obligations to customs authorities are met. It is the IOR’s responsibility to calculate and manage the payment of duties and taxes which can vary from country to country.
- Product Handling: the IOR oversees the receipt, storage and distribution of clinical trials materials ensuring that they are stored appropriately and are available when required.
There are many benefits of using an Importer of Records. Sponsors can focus on their main goal of the clinical research being undertaken with complete peace of mind, knowing that their IOR is working behind the scenes ensuring the smooth running of the trial by meeting regulatory requirements, managing finances and arranging logistics for the delivery of materials.
IOR Services from Oximio
Oximio has been successfully providing complete, end-to-end, clinical trial services for over 19 years. With our Importer of Records (IOR) expertise and in-house team of local regulatory specialists, we assist our clients in defining and managing potential distribution challenges, taking into account temperature requirements and monitoring throughout the transit process.
We can provide a tailored custom brokerage service which include thorough regulatory assessments at the initial phases of the clinical supply chain planning process. All Oximio sites possess the relevant WDA licences.