Geopolitical Risk Is Reshaping Clinical Trial Supply Chains

A conversation with David Fairnie, principal consultant, BSI Group

Clinical trial supply has always operated within complex global conditions, but recent geopolitical instability and energy market volatility are introducing a new level of sustained disruption. Changes in fuel pricing, constrained logistics capacity, and regional instability are no longer isolated events. They are increasingly shaping how investigational products are distributed, stored, and delivered to sites and patients.

For clinical supply leaders, the challenge is not simply responding to disruption but rethinking the assumptions that underpin supply chain design, risk management, and operational execution. Decisions around inventory strategy, logistics partnerships, and regulatory engagement now carry greater weight as teams work to maintain trial continuity in an unpredictable environment.

In this Q&A, Elizabeth Urbanek, executive editor of Clinical Supply Leader, speaks with David Fairnie, the principal consultant at BSI Group, to discuss how these global pressures are impacting clinical trial supply chains and outline practical approaches for strengthening resilience, improving visibility, and protecting study timelines.

Q1: As oil prices rise and geopolitical tensions increase, what specific risks are emerging for clinical trial supply chains — particularly in areas like investigational product distribution, cold chain, and global site coverage?

The Middle East conflict has triggered multiple interconnected shocks across energy markets, logistics capacity, and geopolitical risk. For clinical trial supply, this means the risk profile has shifted in nature, not just severity.

Investigational product distribution is being squeezed from both ends: fuel volatility has driven freight costs sharply upward while carrier capacity through the Gulf has contracted. Cold chains are particularly exposed as most clinical logistics programs are built on the assumption of competitive carrier markets and stable energy pricing, conditions that no longer hold. When a cold chain solution fails under disruptions, you lose product, time, and in some cases patient access to an active trial.

The most underappreciated risk is global site coverage. Sponsors have built trial footprints into regions that are now either within the disruption zone or immediately downstream of it, and most clinical supply teams are discovering their rerouting assumptions were overly optimistic.

Q2: How should clinical supply teams adapt their risk assessment and mitigation strategies when external disruptions — such as fuel volatility or regional instability — threaten trial continuity?

This is not a moment for incremental adjustment; it is a moment for supply teams to fundamentally question the assumptions on which their current risk frameworks are built. Most clinical supply risk assessments were designed for acute, recoverable events: a carrier failure, a port delay, a customs hold. They were not designed for sustained disruption, where instability itself becomes the operating baseline.

The required adaptation is both analytical and structural. Analytically, teams need to move from single-point risk identification to planning that explicitly models scenarios where disruption conditions persist for 12 to 18 months.

Structurally, mitigation must be built into the supply chain architecture: prepositioned inventory, prequalified secondary carriers, and preauthorized regulatory pathways for site substitution. These cannot be improvised under pressure.

The supply teams managing best right now treated geopolitical risk as a permanent operating variable before this crisis began. That is the mindset shift this environment demands.

Q3: What role do serialization and track-and-trace capabilities play in improving visibility and control across clinical trial supply chains, especially during periods of disruption?

Under normal conditions, serialization and track-and-trace are compliance and chain-of-custody tools. Under disruption conditions, they become something more fundamental: the difference between knowing where your product is and hoping it arrived.

When logistics networks are under stress — rerouting, carrier substitutions, extended and unpredictable transit times — the risks increase substantially, including product loss, temperature excursion, and chain-of-custody failure. Serialization gives you the visibility to detect failures early, before they become patient safety events or protocol deviations. Track-and-trace allows for real-time intervention decisions: hold at an intermediate node, trigger a replacement batch, escalate to the sponsor.

What I consistently observe is that clinical supply programs have invested in serialization for regulatory reasons, without building the operational processes to act on what it tells them. In a disruption environment, that gap becomes critical.

Q4: With economic uncertainty putting pressure on hiring, where are clinical trial supply organizations most vulnerable from a talent and capability standpoint?

Vulnerability is concentrated in two areas. The first is specialist logistics and regulatory expertise for nonstandard markets – specifically, individuals who can navigate customs clearance, import licensing, and cold chain compliance outside established clinical supply corridors. That knowledge is tacit, hard to recruit, and cannot be developed quickly. When disruption forces rerouting into unfamiliar markets, its absence is felt immediately.

The second is crisis decision-making capability at the operational level. Clinical supply organizations excel at executing established processes. However, many lack the structured analytical capability required to make sound decisions when those processes break down and judgment is required under uncertainty. This is a distinct skillset and one that is often underrepresented in hiring and development frameworks.

Economic pressure on headcount is exacerbating both gaps. When teams cut to the core, these are the first capabilities to disappear.

Q5: What are the most effective contingency planning strategies sponsors can implement today to protect clinical trial timelines from logistics and supply chain instability?

Three actions will have material impact, and none require long lead times.

Firstly, preposition inventory strategically rather than managing to minimum site stock levels. When transit times are unpredictable, just-in-time models that work in stable conditions become a liability. Buffer stock at regional depots or investigational product hubs creates the response time needed to manage disruption without affecting patient supply.

Secondly, qualify secondary and tertiary logistics partners now, before they are needed. The time to negotiate with an alternative carrier is not when your primary has declared force majeure. Prequalification, pricing frameworks, and operational handoff procedures should already be in place and tested.

Lastly, engage regulatory authorities early on contingency scenarios. Regulators in most major markets have shown a willingness to engage pragmatically on supply chain contingencies, but they need time and documentation. Sponsors who have opened that dialogue already are in a materially better position than those who will need to initiate it under pressure.

Q6: How can clinical supply leaders balance cost containment with the need to build more resilient supply networks, particularly as global risks become more frequent and less predictable?

The framing of "balance" is itself part of the problem. It implies a trade-off — that resilience adds costs while efficiency reduces it. That framing made sense when disruption was episodic and recovery to the previous state was the expected outcome. It no longer holds when disruption has become a persistent operating condition.

The more useful frame is risk-adjusted total cost. A supply network optimized purely for cost efficiency carries a risk of trial delay, patient impact, and protocol deviation that has a real financial value that simply does not appear in the logistics budget. When you model that cost explicitly, the investment case for resilience looks very different.

About the Expert:

David Fairnie is a principal consultant at BSI Group, specializing in supply chain security and organizational resilience. He works with global life sciences organizations on supply chain risk, resilience strategy, and crisis preparedness.