case study
Clearance in hours: excellent services for the patient
Customer profile
CROs are involved in studies with high-cost medications and narrow therapeutic windows, where customs delays can compromise treatment and patient enrollment.
Fax services involved
Regulatory consulting and technical framework.
Preparation of reports, expert opinions, and clinical dossiers for import.
Challenge
Some critical shipments historically faced the following challenges:
- Last-minute documentation requirements.
- Divergent interpretations regarding regulatory and fiscal frameworks.
- Unpredictable clearance times, turning clinical scheduling into an exercise of trial and error.
- The delays worsen on non-working days, and there is a lack of specific standardization for clinical research.
The client needed a capable partner, already familiar with clinical research procedures and working in extreme situations, with a precise understanding of regulations, robust documentation, and a real ability to expedite the process.
How FAXE operated
FAXE has taken over the customs clearance process, combining regulatory expertise and integrated operations.
- Preparation of complete and accurate documentation, aligned with the requirements of the clinical research niche and the specific characteristics of the products (IPs, biologics, radiopharmaceuticals, etc.).
- Working with our own customs brokers, dedicated to clinical research and pharmaceutical follow-up, drastically shortens the cycle of questions and answers with the responsible authorities.
- Anticipating critical scenarios: prior review of documentation, simulation of questions, and definition of strategies to minimize the risk of requirements.
- Transparent and continuous communication with the CRO, with more realistic timeline forecasts and near real-time alerts on each stage of the clearance process.
Results for the study and for the patient
- In critical shipments, customs clearance times have been reduced from typical windows of days to just a few hours, allowing medications to reach centers while still within the clinical windows for inclusion and treatment.
- Significant reduction in requirements and rework, thanks to the quality of reports, expert opinions, and classifications.
- Consulting work by the FAXE team of experts.
- Increased confidence from sponsors and clinical teams in the predictability of the import flow, especially in stressful/disaster situations.
