Clinical Supply Chains Need To Solve Problems Before They Happen

By Laura Hay, senior director of global program management, Trax Group | 2025 Winner, everywoman Customer/Passenger (Leader) Award

One of the biggest challenges in clinical supply is that plans rarely unfold exactly as expected. Enrollment changes, timelines shift, shipments are delayed, and a change in one part of a trial can have a much bigger impact somewhere else.

I think the question for supply chain leaders is not whether something will change. It is how prepared we are to respond when it does.

Planning For More Than One Outcome

Clinical supply plans are built around assumptions about patient enrollment, product demand, manufacturing timelines, and delivery schedules. Those assumptions are important, but they need to be challenged as circumstances change.

If enrollment accelerates in one region, does the inventory strategy still work? If a shipment is delayed, what options are available? If a protocol amendment changes demand, how quickly can the supply plan adjust?

These are the questions teams need to be asking before they find themselves under pressure.

Assessing the risk also means looking beyond the current inventory balance. Teams need to compare expected demand with usable stock, account for replenishment lead times, and determine how much time remains to respond. Inventory that appears sufficient today may not cover demand through the next expected delivery, particularly if enrollment continues to increase.

Consider a trial in which enrollment accelerates at sites in one country while a replenishment shipment is delayed. The original supply plan may still look reasonable at the global level, but the inventory available in that country could run short before the next shipment arrives. The team needs to assess site-level inventory, expected patient demand, remaining product shelf life, and the likely arrival date of the delayed shipment.

Those details shape the available options. The team might be able to reallocate suitable inventory from another location, expedite a shipment, or adjust a replenishment plan. Each option has consequences for cost, timing, and inventory available elsewhere. The right response depends on the trial's requirements and whether the alternative can be executed in time.

In global clinical trials, something that appears relatively small in one part of the process can have a much bigger impact somewhere else. That is why supply planning needs to account for the wider picture, rather than looking at individual decisions in isolation.

Data Is Important, But It Is Not The Whole Answer

Having better visibility into inventory, demand, and shipments can help teams identify potential problems earlier. The earlier teams spot a trend or a risk, the more options we have.

That visibility is most useful when teams can connect the information to a decision. A change in enrollment forecasts, for example, may not require immediate action if existing inventory can cover the additional demand. But if the change coincides with a manufacturing delay or a long replenishment lead time, the same forecast change may require the team to reassess its supply strategy.

But data on its own is not enough. You need people who understand the operational and commercial implications and have the authority to make decisions.

Technology can highlight a potential issue, but teams still need to determine what it means for the trial and what action to take.

Flexibility Requires Trade-Offs

I also think it is important to be realistic about trade-offs. You cannot always have the lowest cost, the fastest delivery, the greatest flexibility, and the lowest risk at the same time.

Clinical supply leaders need to understand what matters most for a particular trial and make deliberate decisions about where flexibility is needed.

That may mean positioning inventory differently, developing contingency plans, or improving coordination between clinical operations, supply planning, and logistics partners.

These decisions also need clear ownership. Supply planning may identify the inventory risk, while logistics assesses alternative shipping options and clinical operations confirms the likely effect of enrollment changes. Quality and regulatory requirements may also affect which options are permissible. Agreeing in advance on who assesses the risk, who can authorize a response, and when an issue must be escalated can help prevent a time-sensitive decision from stalling.

The goal is not to predict every possible disruption. It is to understand the biggest risks, challenge the assumptions behind the plan, and make sure the team knows how to respond.

Clinical trials will always involve uncertainty. Being prepared to adapt is what helps keep supply moving and patients supported.

About The Author:

Laura Hay is senior director of global program management at Trax Group and the 2025 winner of the everywoman Customer/Passenger (Leader) Award. With extensive experience in clinical supply chain and program management, Laura focuses on helping organizations navigate complex global supply environments, improve operational visibility, and build more resilient approaches to clinical trial supply. Her expertise spans clinical supply planning, forecasting, inventory agility, global logistics, and the evolving challenges facing life sciences organizations.