Managing Risk in Clinical Trial Supply Chains: Best Practices for CROs
Clinical trials are becoming more global, more complex, and more time-sensitive than ever before. With decentralised models, emerging market expansion, and an increasing reliance on temperature-sensitive materials, supply chain risk has become one of the most significant challenges for Contract Research Organisations (CROs).
A single disruption - a customs delay, a lost batch of kits, a temperature excursion - can cause scheduling issues, protocol deviations, data integrity threats, or even total trial failure. The stakes could not be higher.
At Arca BioLogistics, we work with CROs worldwide to help them identify, mitigate, and prevent supply chain risks across clinical studies. This article explores the most common causes of supply chain interruptions and outlines best practices CROs should adopt in 2026 and beyond to ensure reliability, sustainability, and operational efficiency.
Why Clinical Trial Supply Chains Are Uniquely Vulnerable
Unlike traditional logistics, clinical supply chains include:
Temperature-sensitive biologics and IMPs
Complex customs and regulatory requirements
Irreplaceable patient samples
Multi-stakeholder coordination across sites
Tight timelines that cannot be easily adjusted
Strict GCP/GDP compliance expectations
The sector must balance scientific precision with logistical agility — a combination that can expose vulnerabilities if not tightly controlled.
For CROs, supply chain excellence is no longer just a supporting function. It is a core determinant of trial success.
Key Risks in Clinical Trial Supply Chains — and How to Mitigate Them
1. Temperature Excursions
Temperature excursions remain the leading cause of product loss in clinical trials. Many clinical materials — from vaccines to cell therapies — degrade rapidly when exposed to incorrect ranges.
Common Causes
Inadequate packaging or poorly validated solutions
Long layovers or delays during international transit
Mishandling by carriers unfamiliar with life sciences requirements
Unmonitored temperature during last-mile delivery
Best Practices for Prevention
Use validated, multi-temperature packaging systems
Passive and active systems must be designed to maintain stability across realistic transit durations and climates.
Deploy reusable smart loggers for real-time insight
Arca’s reusable loggers provide continuous, live temperature visibility, allowing for rapid intervention.
Choose partners with proven cold chain expertise
Generic carriers lack the knowledge to protect sensitive materials consistently.
Validate every route
Environmental mapping of lanes is essential — different routes have different risk points.
Use the Arca Live™ portal for end-to-end visibility
Real-time tracking reduces risk by allowing CROs to act before temperature deviation becomes a failure.
2. Customs Delays and Cross-Border Disruptions
Global trials increasingly depend on cross-regional logistics. But customs issues can lead to severe delays — or complete shipment rejection.
Common Causes
Missing or inaccurate documentation
Incorrect commodity classification
Varied regional interpretations of GDP/GxP requirements
Security restrictions or inspections
Inexperienced customs brokers
Best Practices for Prevention
Pre-clear documentation with experienced specialists
Arca’s customs team ensures every requirement is understood and met before dispatch.
Use consistent routes with proven performance
Reliability stems from repeatability — validated lanes greatly reduce customs risk.
Maintain unified digital records
Regulatory bodies may request temperature logs, chain-of-custody records, or IMP documentation quickly.
Train internal teams on global compliance
Many customs issues originate before the shipment leaves the CRO.
Implement live exception alerts
If delays occur, early awareness can allow for re-routing or risk mitigation.
3. Inventory Errors and Supply Shortages
Inventory issues often result in patient visit cancellations, protocol deviations, or site frustration. Even in highly centralised trials, forecasting errors are common.
Common Causes
Poor forecasting models
Manual record-keeping
Improper temperature storage at trial sites
Delayed resupply shipments
Lack of visibility between CROs, sponsors, and depots
Best Practices for Prevention
Adopt digital inventory management tools (integrated with logistics)
Systems like Arca Live™ allow CROs to track stock levels across global sites.
Centralise temperature and shipment reporting
Fragmented systems lead to inaccurate forecasting.
Use packaging and routes that minimise product loss
Each prevented excursion preserves valuable stock.
Build predictive resupply models
CROs should forecast demand based on projected visit schedules and historical use.
Standardise IMP storage protocols across sites
Variability creates inconsistency — a major regulatory risk.
4. Poor Communication Between Supply Chain Stakeholders
Clinical trials rely on operational harmony. Yet many disruptions stem from misalignments between sponsors, CROs, depots, and sites.
Common Causes
Disconnected systems
Slow manual reporting
Unclear responsibilities
Failure to share temperature or chain-of-custody data
Out-of-date trial protocols
Best Practices for Prevention
Unify communication into a central platform
Arca Live™ provides a single location for all logistics updates, removing ambiguity.
Establish real-time alert workflows
Everyone involved must know when action is required.
Conduct regular cross-stakeholder logistics reviews
Identify risks before they escalate.
Provide sites with simplified instructions and ready-to-use shipping materials
Complexity creates errors — simplicity reduces them.
5. Lack of Sustainability Controls
Sustainability is now tied directly to compliance, funding, and corporate responsibility.
Common Causes
Excessive single-use packaging
Inefficient route planning
Over-ordering due to inventory uncertainty
Lack of carbon reporting data
Best Practices for Prevention
Use reusable packaging and loggers
Arca’s systems reduce waste across all temperature ranges.
Introduce carbon offsetting for all international movements
CROs gain measurable ESG improvement.
Reduce spoilage by improving monitoring
Every avoided loss strengthens sustainability outcomes.
Use optimised routing to reduce emissions
Validated lanes allow for greener shipments without risking integrity.
How Arca BioLogistics Supports CROs in Reducing Supply Chain Risk
Arca’s model is designed around the realities CROs face every day:
Sustainability
Reusable systems, carbon offset options, and decreased material waste support both ESG goals and regulatory expectations.
Reliability
Predictable transit times, validated routes, and Arca Live™ transparency give CROs complete peace of mind and full data integrity.
Time & Efficiency
CRO teams spend less time managing logistics — an average 84% reduction in pre-shipping time — and more time driving trial success.
Our clients consistently report reductions in:
Shipment delays
Excursions
Administrative burden
Compliance risks
Costs associated with spoilage or emergency resupply
Conclusion: CROs Must Turn Supply Chains Into a Strategic Advantage
Clinical trial supply chains are rapidly evolving. As trials become more global and biologic-heavy, risk management must be embedded into every stage of logistics planning.
By adopting:
Smart temperature-controlled systems
Unified digital platforms
Sustainable packaging and routing
Predictive analytics
Expert logistics partnerships
CROs can transform their supply chains from points of vulnerability into foundations of reliability, compliance, and scientific integrity.
If your organisation is looking to reduce supply chain risk and improve trial reliability, now is the time to partner with Arca BioLogistics. Let us help you build a supply chain built for modern clinical research.