The timely delivery  of medical devices and ancillary equipments  during  early-phase clinical  trials  is integral as delays can push back study schedules and extend trial duration. Protocol adjustments may also be necessary as a result of these delays, which would hinder approvals and involve more paperwork. Sponsors frequently turn to new equipment or expedited shipping to fill the gaps, which raises expenses and depletes resources. Managing time-sensitive shipments becomes especially complex in multiregional clinical trials (MRCTs), where variances in customs and other mandates associated with cross-country logistics pose significant challenges. This is where the role of Importer of Record (IOR), and Exporter of Record (EOR), come in, which are legal entities responsible for handling complex and diverse customs requirements associated with medical devices, Investigational Medicinal Products (IMPs) and ancillary supplies across international borders.

The early phase clinical trials (preclinical, Phase I, and Phase II) discuss the initial testing of new medical techniques and interventions with the focus on safety and preliminary efficacy. In addition to the investigational medicinal products, these trials depend on medical devices, ancillary equipment such as infusion pumps, monitoring devices, and various surgical instruments, to maintain patient safety, preserve the integrity of the trial, and collect accurate data. In the case of MRCTs, the transfer of such equipment across borders becomes a regulatory and customs issue, and the function of IOR and EOR becomes critical to ensuring control and timely release of these shipments.

This article focuses on the key aspects of the timely provision and safe management of medical devices and ancillary equipment throughout early phase clinical studies, and highlights the importance of early involvement of IOR and EOR in carrying out such functions across international borders in MRCTs. 

Advantages of early shipment planning in clinical trial preparation

Early shipment planning is critical to the uneventful conduct of clinical trials, especially in the on-time delivery of medical equipment, auxiliary supplies, and other important materials. By incorporating a comprehensive plan into the trial protocol at the initial planning phases, sponsors and CROs get the benefit of preserving study timelines, and decrease the risk of operational hindrance. 

The following are the advantages of early shipment planning in clinical trial preparation:

1. Timely availability of product and patient treatment: This ensures a patient’s treatment plans are not compromised as investigational products including comparators, medical devices, ancillaries, lab kits, and documents must be in place before patient recruitment begins. 
2. No delays in customs clearance, and import/export permits: This helps in cutting costs for extra operational expenses and minimize delays in study timelines. 
3. Ensures compliance with regulatory requirements: Early planning helps in avoiding any compliance conflict or breaches and easily navigates regulatory paperwork.
4. Prevents site activation delays: Delays in starting a trial are preventable as it minimizes the risk of missing or insufficient supplies.
5. Provides room for contingency plans: Alternative suppliers or backup couriers could be managed beforehand.
6. Supports multi-country trials: Early shipment essentially solves varied import/export requirements in multi sites across borders on time.
7. Enables smooth execution of trials: Supports coordinated delivery across geographical boundaries, ensuring clinical trials to run smoothly. 

Essential regulatory documentation and the crucial role of IOR/EOR in cross-border shipments

For clinical trial shipments, it is mandatory to meet the regulatory and customs standards, requiring the following essential documents: Import/Export license, certificate of analysis (CoA), commercial/customs invoices, material safety data sheets, regulatory approvals & permits, packing lists & waybills.  

Role of IOR/EOR

The IOR/EOR are important legal entities in multiregion or international clinical trials. They ensure all shipments comply with local import and export regulations. This prevents delays and helps maintain trial timelines. In simple terms, IOR handles imports of investigational products, devices, or ancillaries. EOR is responsible for exporting regulated materials from the country of origin. When moving materials across borders, compliance with regulations, customs, and taxes is critical. Because early phase clinical studies are frequently time-sensitive, choosing or collaborating with the appropriate IOR/EOR is essential.

How IOR/EOR support documentation needs in early-phase clinical trials across countries

1. In each nation, IOR/EOR partners determine which licenses are necessary, apply for them with the appropriate authorities, and make sure they are approved prior to shipment. 
2. In order to avoid rejections and customs inspections, the IOR confirms that the documents provided by the manufacturers satisfy the requirements set forth by the health authorities of the concerned nation. 
3. They create or verify shipping labels and invoices using the appropriate Harmonised System codes, product details, and declared values that differ between customs authorities.
4. IOR partners also assist in determining whether certain materials require regulatory permissions or ethics clearances.
5. They ensure that documentation accurately reflects the contents of shipments, facilitating seamless inspections and real-time tracking. 

The IOR/EOR acts as the local regulatory body for sponsors or CROs. It oversees documents and aligns compliance with national requirements.

Country-specific shipment regulations for clinical trials

Clinical trial material shipment regulations vary greatly between nations, which makes multi-regional trials difficult. Sponsors and CROs must compare these regulations in order to guarantee compliance, prevent delays, and safeguard data integrity. Import and export processes in Japan, China, and Switzerland are challenging. These countries apply strict rules to pharmaceuticals and medical devices.

For instance, Japan demands a local Importer of Record, PMDA approval, and stringent GDP and labelling compliance. Shipments may be refused for even small documentation or translation problems. All clinical trial imports must pass quarantine inspections in China, which frequently causes weeks-long delays in release. Shipments in the cold chain are subject to additional examination, and any variations may result in the rejection of the goods. Under Swissmedic, Switzerland requires exact licenses and conformance records along with stringent customs inspections. Its distinct clearance regulations, as a non-EU nation, make trial logistics much more difficult.

To learn more about country-specific processes, read our articles on Japan’s IMPs import regulatory & process and the importation of clinical ancillary supplies for clinical trials in China. 

Compliance and accountability in shipment management

This section highlights the critical aspects of GxP compliance, regulatory alignment, and the legal accountability of all stakeholders, including sponsors, CROs, and IOR/EOR partners. 

1. IORs and EORs ensure compliance with GxP standards, including GCP, GDP, and GMP.
2. While IOR/EOR partners handle the operational side of cross-border shipments, the trial sponsor is responsible and accountable for overall trial compliance. Understanding who is accountable for what can prevent serious legal and regulatory risks. 
3. IOR/EOR is also liable for non-compliance fines pertaining to taxes, customs, or regulatory violations. 

Effective IOR/EOR cooperation for proactive risk management

International logistics are complex, and strict regulations apply. Effective IOR/EOR cooperation is crucial to reduce risks in shipments. Sponsors can build strong frameworks that minimize delays, ensure compliance, and handle disruptions by focusing on a few key areas.:

1. Selecting qualified IOR/EOR partners: Choose providers with strong knowledge of customs laws and trial regulations. This prevents compliance errors and reduces shipment delays.
2. Harmonized documentation & pre-clearance: Using standardized templates for documents ensures consistency across shipments. Moreover the IOR/EOR can make a pre-custom clearance for all shipments electronically even before it arrives. 
3. Service agreements: Draft a clear agreement defining which trial duties transfer from sponsor to CRO and/or logistics partner.
4. Establish communication protocols: Create effective, documented procedures for decision-making and communication in an emergency.
5. Frequent interaction and verification of conformity with the IOR/EOR: Keep lines of communication open and constant with your IOR/EOR partners. 

Checklist for sponsors and CROs: engaging IOR/EOR expertise early in the process

1. Early alignment with documentation and compliance.
2. Utilizing IOR/EOR knowledge.
3. Unifying documentation in different jurisdictions.
4. Ensuring appropriate packaging and labelling.
5. Using early IoR/EoR collaboration to manage risk and accountability.
6. Developing a cooperating partnership with IoR/EoR for sustainable achievement.

Conclusion

Implementing Importer and Exporter of Record (IOR/EOR) services early is crucial for the success of early-phase clinical trials. Early engagement of IOR/EOR specialists aids sponsors in meeting regulatory standards, preventing delays, and maintaining trial timeliness. Additionally, it guarantees that the right documentation is in place, which lowers the possibility of customs issues. Moreover, faster site activation and a seamless trial execution are supported by this early coordination. 

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