This Assumption Will Break Your Clinical Trial
By David Fairnie, principal consultant, BSI Group
Every clinical supply professional I speak to right now is operating under the same embedded assumption. It is rarely stated explicitly, but it shapes every decision being made within RTSM-based clinical trial supply planning systems. They believe that the current disruption is temporary, that the situation will resolve, and that the task at hand is to manage through until it does.
That assumption is wrong. In clinical trial supply, where the consequences of supply failure are measured in patient access and trial viability, it is the most dangerous planning error an organization can make within end-to-end RTSM-driven supply networks and depot distribution channels.
Disruption Reveals Your Supply Chain’s Flaws
When the Strait of Hormuz closed to contested traffic, clinical supply teams activated their contingency plans within existing clinical trial supply distribution workflows and IRT-driven logistics rulesets. This meant engaging alternative carriers, exploring rerouting options and reviewing inventory buffers. For some organizations, those plans held. For many, they discovered that their contingencies were optimized for short-duration, single-vector disruption – such as a carrier failure, a port delay, or a weather event. That is not what is actually happening here; it’s an indefinite, multi-vector disruption with no resolution timeline and no recovery horizon in sight, breaking assumptions embedded in RTSM forecasting and supply replenishment logic
In practice, this means shipments that once moved in predictable 48- to 72-hour lanes now require routing decisions that change depending on daily port clearance status, insurance coverage for specific vessels, and depot tolerance for variable arrival windows without triggering RTSM replanning or downstream kit rebalancing.
Peace talks have stalled. The dual blockade – the U.S. interdiction of Iranian traffic alongside Iran's continued restrictions on vessels it deems hostile – has created a strait that is contested, partially mined, and navigable only under specific arrangements for a narrow set of nations. There is no Scenario A here, nor is there a managed deescalation with a visible endpoint. What exists is a permanent operating condition of elevated disruption, variable in intensity but not in direction.
Clinical supply chains were not designed for this. They were designed for a world in which disruption is the exception and stability is the baseline. That world has gone, and it is unknown when – or if – it will return.
Most clinical trial supply networks still operate on fixed replenishment cycles linked to forecasts in RTSM or ERP forecasts that assume stable transit times and predictable depot release windows, which breaks down when shipping lanes become dynamic or politically restricted and when kit assignment logic within IRT systems no longer reflects real logistics conditions.
The Recovery Trap In Clinical Supply
The clinical supply community has responded to the past five years of successive crises with considerable ingenuity. COVID reshaped decentralized trial models, while Red Sea disruption prompted carrier diversification. Each time, the industry adapted, and when conditions improved, it reverted. Contingency became a lesson learned and then became a footnote, which became the next crisis's blind spot.
This often meant that secondary depot strategies, expedited kit reorder pathways, and emergency labeling processes were never fully validated under live trial conditions within active RTSM environments, making them unreliable when real disruption occurs.
This pattern reflects a structural assumption: that recovery to the previous baseline is both possible and probable. Build enough redundancy to manage the disruption period and then optimize back to efficiency once it passes.
That assumption has now been invalidated. Not by opinion, but by the cumulative evidence of the past five years. COVID did not normalize – it restructured decentralized delivery permanently. The Red Sea crisis did not normalize either – it permanently revalued chokepoint risk and insurance pricing for Gulf routes. The Hormuz situation will not normalize on any timeline relevant to a trial currently in execution. Sponsors managing active trials need to stop asking "How do we get through this?" and start asking "How do we operate in this?"
For example, in multiregional trials, a single port closure can force a complete shift in depot allocation logic, where patient randomization windows become constrained not by protocol design but by which depots can guarantee kit release within valid expiry and temperature parameters under GDP-compliant depot operations and RTSM controlled release rules.
The Real Need In Clinical Trial Supply Chains Isn’t Contingency — It’s Architecture
A contingency plan answers the question: what do we do when something goes wrong? It assumes a right state from which the wrong state is a deviation. It is designed to restore, not to sustain.
What the current environment demands is a different design question entirely: how do we deliver reliably when instability is the operating condition, not the exception? That requires changes to supply chain architecture, not the plans that sit alongside it.
In practical terms, that means three things.
Firstly, inventory strategy needs to shift from just-in-time to risk-calibrated positioning. Strategic buffer stock at regional hubs, prepositioned against disruption scenarios rather than demand forecasts, is not overhead. It is the operational margin that protects patient supply when transit becomes unpredictable. The cost of holding that inventory is a fraction of the cost of a protocol deviation or a trial delay.
This also changes how RTSM systems must operate, shifting from static supply forecasting to scenario-based kit allocation, where inventory is reserved against contingency states rather than pure enrollment curves within configured allocation rulesets.
Secondly, carrier and logistics relationships need to be structural, not transactional. Prequalified secondary and tertiary partners, with negotiated frameworks and tested handoff procedures, cannot be established under pressure. They need to exist before the pressure arrives, which means now, not when the next disruption event triggers an emergency sourcing exercise.
This requires pre-agreed escalation flows between sponsor, depot, and logistics provider that define exactly when shipments are rerouted, held, or reallocated without waiting for central approval delays and without breaking RTSM-driven supply continuity rules.
Thirdly, regulatory engagement on contingency scenarios needs to be proactive and ongoing, not reactive. Regulators in most major markets have demonstrated pragmatism on supply chain contingencies when sponsors engage early and with proper documentation. The organizations that have opened those dialogues already are in a materially different position from those who will initiate them mid-crisis.
This also extends to country-level import permit variability, where regulatory filings must anticipate route changes in advance rather than be updated after a logistics disruption occurs within clinical trial material importation and customs workflows.
None of these are novel ideas. What is novel is treating them as permanent features of clinical supply architecture, rather than temporary crisis measures to be wound down when conditions improve.
The Question Executives Need To Answer
In the past few months, I have spoken with clinical supply leaders across multiple sponsors. The most important question I ask is not "What is your contingency plan?", but rather, "What does your supply chain assume about the world it operates in?"
If the answer, whether explicit or implicit, is that the world is stable with periodic disruptions, the architecture is wrong. If the investment case for resilience is still being framed as insurance against unlikely events, the framing is wrong. If the measure of a successful supply chain is efficient at baseline, the measure is wrong.
One practical way to test this is to trace a single kit from manufacture through depot release to patient delivery and identify every point where a human decision or system rule assumes transport stability within RTSM-dependent clinical supply workflows. Those assumptions are where most real-world failures begin.
The organizations that will protect their trials, their patients, and their programs over the next two to three years are those that have accepted a simple uncomfortable truth: the operating environment has changed permanently, the disruption is not a phase, and there is no road back to the baseline their supply chains were designed for.
The task is not to recover. The task is to redesign.
About The Author:
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.