Tigermed EMEA Articles

The critical role of logistics in clinical trials: why research cannot advance without it

Written by Tigermed EMEA | Dec 6, 2025 5:46:27 PM

In the world of clinical trials, the success of a drug or medical device does not rely solely on science, protocol design or investigator expertise. One element that remains invisible to the public, yet is absolutely essential for data quality and patient safety, is logistics.

 

From transporting the investigational medicinal product (IMP), to managing biological samples and ensuring compliance with international regulations, a specialized logistics provider represents the operational backbone of every clinical study.

 

1. IMP integrity: the first step toward valid data

 

Every clinical trial begins with an IMP that must reach sites in perfect condition.

A professional logistics company ensures:

 

  • controlled-temperature transport

  • validated packaging

  • continuous monitoring

  • immediate action in case of deviations

 

If the temperature chain is broken, the drug may become unstable, compromising data reliability.

 

2. The cold chain – an infrastructure that cannot fail

 

Advanced therapies, biologics, vaccines and many modern molecules require precise cold-chain conditions: 2–8°C, -20°C or even -80°C.

 

Without robust logistics, the risk of product loss, stability issues or significant delays increases dramatically.

Specialized logistics providers offer:

 

  • long-duration validated packaging

  • integrated temperature sensors

  • time-critical transport

  • GDP-compliant storage

 

3. Handling biological samples – critical time, critical route

 

Biological samples such as blood, plasma, tissues, DNA or PK/PD materials are extremely sensitive.

To remain valid, they must be transported:

 

  • within narrow time windows

  • under precise temperature conditions

  • with complete documentation

  • in compliance with IATA and GxP standards

 

Specialized logistics ensures optimized routes, validated containers and full traceability from site to central lab.

 

4. Navigating international regulations and customs requirements

 

Multicenter trials involve cross-border shipments with different national regulations.

A specialized logistics partner handles:

 

  • export/import documentation

  • proper material classification

  • customs inspections

  • compliance with transport rules for sensitive materials

 

This prevents delays and reduces operational risks.

 

5. Digital traceability and real-time monitoring

 

Modern logistics provides full transparency through:

 

  • real-time track & trace

  • automated temperature alerts

  • electronic proof of delivery (ePOD)

  • complete audit-ready reports

 

This enhances safety, reliability and operational efficiency.

 

6. Study continuity: a trial never stops

 

Good logistics prevents situations with major impact:

 

  • temporary IMP shortages

  • cancelled patient visits

  • delayed randomization

  • unexpected increases in study costs

 

In clinical research, a delay of days can translate into months of operational consequences.

 

7. 24/7 support for critical situations

 

Clinical trials involve real patients, and urgent needs can arise anytime.

A logistics company must be able to respond rapidly through:

 

  • next-flight-out shipments

  • urgent temperature-controlled deliveries

  • quick relocation of IMP or samples

  • non-stop operational support

 

This flexibility ensures uninterrupted treatment and patient safety.

 

Conclusion

 

In an increasingly complex landscape of medical development, logistics becomes a strategic partner for sponsors, CROs and clinical sites.

Without professional management of transport, storage, biological samples and international documentation, no clinical study can run efficiently or compliantly.

 

Logistics is the silent mechanism that enables science — and when it works flawlessly, research advances quickly, patients remain safe, and data stays reliable.

 

Why choosing the right logistics partner is essential

 

Because patient safety, drug integrity, regulatory compliance and the continuity of the entire clinical study depend directly on logistics performance.

A good choice ensures a smooth, risk-free trial; a poor choice can lead to delays, additional costs and compromised data.