With imports fundamental to the clinical supply chain, a specialist Importer of Record (IoR) can make all the difference in processes running smoothly.
Sensitive biopharma products and biosamples must be transported around the world, but regulations can differ from country to country. Any disruption at borders can have disastrous consequences for a trial’s schedule and budget.
However, managing the documentation and transportation of clinical materials is a considerable undertaking that the sponsor or CRO cannot expect to handle themselves. IoRs are key partners who understand regulatory requirements on the ground and process paperwork at borders, giving sponsors peace of mind and allowing them to focus on their clinical workload.
The role of the IoR: what service do they provide?
As of July 2024, 9.6% of ongoing clinical trials were multinational – more than 6,500 trials, according to GlobalData. The challenges of running a clinical trial in one country are difficult enough, with materials requiring careful handling and complex regulations to be adhered to.
As international import regulations have grown more stringent and complex, IoRs are essential third-party organisations in supporting operations across a variety of industries.
Their local representatives and partners are pivotal in helping to manage taxes, audits, and overall administration, leaving the main party free to concentrate on the essentials of their business.
From executing compliance procedures to documentation, duties, and taxes, IoRs play a crucial supporting role in meeting customs requirements. However, when in the more complex task of managing clinical trial imports, IoRs provide a vital service.
Investigational drugs, medical devices, and biopharma samples scheduled for import are all subject to different regulatory requirements by country. Without IoRs, clinical trial sponsors would have to devote limited time and resources to handle customs clearance and compliance themselves. Sponsors who fail to ensure compliance can be fined – and in a worst-case scenario, even have their goods seized.
To help manage such issues, it is paramount to select an IoR partner with strong expertise in the pharma industry.
Finding a specialist in IoR
Logistics are often underestimated as a challenge in clinical trials, with sponsors often focused on thinking big and making the necessary leaps in scientific advancement. However, attention to the details in documentation and compliance is just as important in making a trial successful as the big-picture goal of innovating life-saving treatments.
A strong IoR partner can make all the difference in facilitating the next generation of revolutionary medicines for patients.
With almost two decades of industry experience, Oximio provides complete end-to-end IoR capabilities for clinical supplies, offering access to a team of regulatory experts who understand the challenges sponsors face. Central to Oximio’s offering is a custom brokerage service, alongside its expertise in clinical supply logistics. Potential in-transit issues are identified such as the temperature needs of a shipment, with solutions suggested and management strategies developed.
To learn more about the role of an IoR in overcoming challenges with international clinical supplies, download the specially commissioned report below.
