Import Project Management Solutions for Clinical Trials
TecEx Medical are the industry experts in importation project management for the clinical trials. We are your go-to IOR and customs compliance partner for importing clinical, medical device, and ancillary supplies.
Complete Clinical Trial Project Management
The clinical trial industry remains one of the most challenging areas of global trade. Companies face customs compliance hurdles in this rapidly advancing market.
Complexities such as country-specific Ministry of Health (MoH) requirements, clinical trial notifications, tariffs, licensing requirements and global trade agreements, are some of the many challenges faced by those in the clinical trial sector.
As a result, clinical trial supply chain management has become the pillar of efficient cross-border distribution.
Supply Chain and Trade Compliance Solutions for Clinical Trials
Stuck shipments of clinical and ancillary supplies, missed Site Initiation Visit (SIV) dates and unexpected tariffs are the worst-case scenario for those conducting global clinical trials.
Yet an estimated 85% of clinical trials experience delays. Regulatory, procedural compliance, and clinical supply chain issues are some of the most common reasons for clinical trial delays.
TecEx Medical’s complete trade compliance and clinical supply chain management solution safeguards your international studies.
We Partner with Sponsors to:
Navigate regulatory requirements across different countries
with expert guidance tailored to each clinical trial import/export market, ensuring full compliance from day one.
Avoid customs delays caused by licensing and documentation errors
by streamlining clinical trial product documentation, import permits, and pre-approvals.
Ensure traceability and compliance for investigational product
through validated, secure clinical trial shipping solutions and audit-ready supply chain processes.
We Partner with CROs to:
Accelerate customs clearance through accurate classification and tax handling
using expert HS code assignments and support with tax exemptions for clinical trial supplies.
Manage complex multi-party coordination across clinical trial stakeholders
with centralized compliance support that bridges sponsors, depots, and investigator sites.
Operate compliantly in countries where they cannot act as Importer of Record
by leveraging our global IOR services for clinical research organizations.
We Partner with Vendors to:
Ensure correct labeling, packaging, and documentation for clinical trial use
with proactive support aligned to regulatory requirements for investigational drugs and medical devices.
Distribute medical devices, eCOA and all clinical & ancillary supplies globally, including emerging markets
with full-service clinical trial logistics and import/export compliance.
Safeguard the cold chain and time-sensitive products during transit
by mitigating delays that may cause cold chain disruptions by working alongside your preferred GDP-compliant partners for pharmaceutical cold chain logistics.
We Partner with Couriers to:
Resolve customs compliance challenges during clinical trial shipments
with access to global regulatory guidance and trusted Importer of Record capabilities.
Access high-risk or restricted import markets with confidence
through our extensive network of customs clearance solutions for clinical trials.
Reduce delivery risks for investigational products
through proactive compliance checks, minimized shipment holds, and faster turnaround times.
Value-added services include:
Importer of Record (IOR)
We’re more than just a consignee; we act as your local and legal representative for importing medical commodities. This means we handle all the paperwork and import requirements for customs clearance so that you can focus on your trial.
Exporter of Record (EOR)
We also help with the export of your clinical trial supplies, which includes exporting medical devices at the end of the clinical trial and facilitating biological sample shipments to central labs. We can support export license applications & filings wherever required.
Licenses and Permits
We apply for all required permits and licenses to import medical commodities. This ensures that your clinical study complies with all origin and destination country compliance requirements.
Trade Compliance
From Clinical Trial Notifications to customs clearance, we manage everything, including customs documentation, regulatory submissions, import registrations, and the payment of duties and taxes. Whether you’re navigating European Union regulations, importing into an isolated country like Australia, or expanding globally, TecEx Medical ensures your clinical trial materials are delivered without delays, penalties, or compliance issues.