Mastering Clinical Trials: The Importance of Drug Sourcing and Logistics

In clinical trials, every element of the supply chain matters. From sourcing high-quality comparator drugs to managing timelines across borders, sponsors often ask: which is the bigger challenge, drug sourcing or the logistics that follow? At Clinical Services International (CSI), we believe the answer isn’t either/or. It’s how you manage both that determines trial success.

Comparator Sourcing: A Global Jigsaw Puzzle

Sourcing comparator drugs can be a significant challenge, particularly when:

• The product is in short supply or under allocation.

• The trial requires access to brands from specific markets.

• There are tight timelines and narrow expiry windows.

• Sponsors need specific batches or documentation, such as Certificates of Analysis (CoAs) or TSE/BSE statements.

• The drug is subject to import/export restrictions.

  
  

These complexities are amplified in regions with fragmented regulatory environments or limited distribution networks. That's why CSI maintains direct accounts with most major manufacturers and a global sourcing network, enabling us to secure even hard-to-source drugs quickly and compliantly.

Clinical Trial Logistics: The Invisible Risk

Even with comparators in hand, the real test often lies in getting those products to the right place, at the right time, and under the right conditions. Logistics hurdles can quietly derail a trial if not proactively managed.

Some of the most critical challenges include:

• Cross-border customs delays.

• Temperature excursions during transit or at storage sites.

• Site-specific import requirements and licensing.

• Mismatched labelling and language translations.

  
  

For global, multi-site, and especially Phase III trials, these risks are magnified. It’s essential to have a comprehensive strategy in place for management.

The Role of Supply Chain Management

CSI’s solution? Integrated supply chain management. We address both the sourcing and logistics to ensure smooth operations.

How CSI Overcomes These Challenges

At CSI, we don’t just source drugs; we de-risk the entire supply chain. Here's how:

Strategic Forecasting & Planning

CSI tailors supply strategies to align with projections, protocol timelines, and product shelf-life. This ensures optimal availability while minimizing waste. Accurate forecasting can prevent both shortages and excess inventory.

Global Warehouse Network

With facilities in over 60 countries, we provide flexible local storage options and rapid deployment capabilities. This logistical advantage enables us to respond quickly to changing circumstances.

End-to-End Distribution

From import/export documentation to temperature-controlled logistics, CSI manages every shipment from door to door with real-time oversight. Our comprehensive approach allows for transparency and awareness.

Regulatory Expertise

Our regulatory team provides site-specific support to ensure local compliance and smooth customs clearance. This is especially crucial in high-risk markets where regulations may change frequently.

Returns & Destruction

Post-trial, we handle compliant product returns, reconciliation, and destruction. This service takes the burden off sponsors and Contract Research Organizations (CROs), allowing them to focus on what they do best.

Conclusion: It’s Not Either/Or. It’s Both

While comparator drug sourcing is complex, particularly during global shortages or tight timelines, the logistical execution can be equally, if not more, fraught with risk. That’s why CSI takes an integrated approach.

By combining sourcing expertise with robust supply chain capabilities, we help our clients move faster, stay compliant, and control costs, from protocol design through to last patient out.

Need help solving a supply challenge? Contact CSI today to find out how we can support your trial from sourcing to final shipment.

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