Clinical Supply Planning In A More Volatile And Regionalized World

By Eugene Suh, managing principal, LTD Consulting

Over the past few years, clinical supply teams have been operating in an environment that feels noticeably less predictable than it once did. Shipping timelines that used to be reliable now fluctuate, raw material lead times stretch unexpectedly, and local regulatory nuances seem to matter more than ever. These challenges are not occurring in a vacuum. They reflect a broader global shift in which energy, commodities, forex exchanges, geopolitics, and regional policy decisions are all playing a larger role in supply chain costs and material availability than they did during the relative stability of past decades. The entire world may well be entering a new paradigm, shifting from globalization to a more protectionist-based economic environment where commodities and real goods become a de facto form of currency. Payment systems, energy markets, and trade routes are increasingly being used as policy tools rather than background utilities. Clinical supply managers don’t need to be economists to navigate this change – but they do need to recognize when age-old assumptions no longer hold true and they should adapt their clinical supply strategies accordingly. Inability to do so can lead to higher costs, greater operational risks, and potential clinical trial supply disruptions over time.

Here are several practical areas where this shift is most likely to impact clinical supplies and what teams can do to adapt without overhauling their entire operating models.

Logistics And Distribution

The period of globalization over the past 50 years greatly shaped the mechanics of clinical supply distribution and logistics. Through economies of scale, globalization allowed cost optimization, access to diverse supplier networks, and streamlined production processes.¹ Shipping lanes became predictable, and fuel costs were manageable. Emergency shipments, when required, were generally viewed as solvable problems rather than existential risks. That operating environment is no longer the norm.

In the volatile and regionalized world clinical supply managers will face in 2026 and beyond, rising and more unstable energy and distribution costs (e.g., tariffs) will permanently alter the economics of global shipping. As overall freight costs increase, the penalties for last-minute or unplanned shipments become significantly higher, both financially and operationally. In practical terms, this fundamentally shifts the logistics strategies for clinical supply teams. Clinical supply managers need to minimize reliance on large, infrequent bulk shipments that require precise timing. Instead, more distributed shipment strategies, such as increased use of regionalized lanes, can reduce the risk of having to resort to emergency freight under unfavorable conditions. Shifting from reliance on bulk shipments, in turn, leads to a new implication for clinical supplies: clinical supply managers will need to develop and maintain accurate long-range demand forecasts for their trials. Through implementing robust forecasting practices, clinical supply managers can reduce the number of shipments needed per trial, thereby reducing the budgetary impact of increasing distribution costs. In addition, accurate long-range forecasting greatly reduces the risk of having unplanned shipments.

Clinical supply managers are also seeing increased geopolitical instability and regional disruptions in recent years. This trend is expected to continue and amplify in 2026 and beyond. These changes, in turn, increase the likelihood that established shipping routes may become unreliable with little notice. How can clinical supply managers adapt to these unstable landscapes? In the article A Commons for a Supply Chain in the Post-COVID-19 Era: The Case for a Reformed Strategic National Stockpile, Handfield et. al. postulate that clinical supply distribution networks will need to lean into “nearshoring, reshoring, and diversification of supplier networks to enhance resilience.”² In essence, loss of interconnectivity will need to be addressed with more reliance on localized IP manufacturers, as well as higher utilization of local depot networks within targeted countries.

Going forward, increased volatility and regionalization will require clinical supply managers to truly integrate logistics into their supply planning in a methodical, detailed manner. In many cases, clinical supply managers will have to incorporate higher costs, flexibility, and resilience into their clinical supply forecasts as they navigate a new logistical reality.

Regulatory Fragmentation And The Growing Complexity Of Execution

While globalization pushed regulatory frameworks toward greater alignment, new localized policies have seen a reversal of that trend. Brexit, for example, is a prime example of what regionalization may look like for clinical supply managers going forward. As many clinical supply managers have already experienced, Brexit created a whole host of new logistical and QP release requirements for clinical supply chains. As the regionalization trend continues, Brexit-type situations may become the new normal. Evidence is already appearing: many regions are currently placing increased emphasis on local control, protectionist policies, and country-specific regulatory requirements. For clinical supply operations, this translates into greater complexity at every stage of execution.

To navigate this changing landscape, clinical supply managers will need to continuously monitor evolving regulatory expectations, not only during trial start-up but throughout the entire lifespan of their clinical trials. Labeling requirements, import/export rules, and QP expectations can change drastically with limited warning, particularly in regions where regulatory policies are closely tied to broader political or economic priorities. Operationally, label grouping strategies will need to become more fragmented to accommodate distinct country-specific regulatory requirements, and supply plans must accommodate a wider range of country-specific constraints. The cost of noncompliance, whether in the form of delays, rework, or lost material, continues to rise.

In the end, regulatory awareness must be embedded directly into the clinical supply planning processes. Clinical supply managers should work closely with regulatory affairs and regulatory CMC to ensure supply chains are aligned with the ever-changing, volatile regulatory landscape. Teams that treat regulatory considerations as downstream checks rather than core planning inputs are more likely to experience disruption as the regulatory environment continues to diverge rather than converge.

Procurement And Raw Materials As A Structural Constraint

One of the more profound effects that a volatile, regionalized world will have on clinical supply chains lies in procurement, particularly for packaging, labeling, and other supporting materials. Clinical supply raw material components (e.g., HDPE bottles, label stock, blister materials, etc.) have historically been viewed as relatively low-risk inputs, sourced late in the planning process with short lead times and predictable availability.

That assumption is being challenged. In 2026 and beyond, global fragmentation is shifting the availability of clinical supply raw materials into the hands of nations that may have political interests that are dichotomous to the U.S. (e.g., BRICS+ nations). For example, the BRICS+ nations currently control 75% of the world’s rare earths, 50% of graphite, 28% of nickel, and >10% of copper.³ This centralization of raw materials, coupled with protectionism, will cause longer lead times and higher costs for common clinical supply items such as blister materials, labels, cartons, and inserts. In many cases, these extended lead times and higher costs are not temporary anomalies but reflections of a tighter and more competitive procurement landscape.

For clinical supply teams, this means that procurement decisions must occur earlier in the planning life cycle, with a fundamental understanding that costs will increase year-over-year and sourcing options may change annually for the same clinical supply raw materials. Material commitments that were once deferred until closer to packaging execution may now need to be secured well in advance. In addition, prioritization decisions, such as favoring continuity of supply over marginal cost savings, will become increasingly important.

The key procurement risk is not simply higher cost but loss of flexibility. When supporting materials become the gating factor, the ability to respond to changes in enrollment, geography, or protocol design is significantly constrained.

Clinical Supply Planning As A Living System

Taken as a whole, these pressures point to a broader conclusion for clinical supply managers: static clinical supply plans are no longer sufficient to manage clinical supplies in a volatile, fragmented operating environment. Forecasts based on fixed assumptions, limited risk mitigation strategies, and infrequent reassessments are increasingly misaligned with reality.

Effective clinical supply planning in 2026 and beyond requires a more adaptive approach — one that treats the supply chain as a living system rather than a fixed set of milestones. This includes regular reassessment of demand assumptions, proactive evaluation of emerging risks, and predefined decision pathways that allow teams to respond quickly without resorting to crisis management. Clinical supply managers will need to develop clinical supply tools that can quickly reassess global demand signals based on changing site inventory, depot inventory, and shifting clinical trial enrollment projections. These tools should also be able to incorporate feedback from logistics, procurement, and regulatory developments, thereby allowing clinical supply managers to anticipate where flexibility is needed and to build it intentionally into the front end of clinical supply strategies. Whereas static spreadsheets were sufficient in past decades, new clinical supply tools may become a necessity to successfully navigate clinical supplies in the new volatile, regionalized world we are entering.

Planning For A Volatile, Regionalized World That No Longer Optimizes For Stability

The macroeconomic and geopolitical shifts influencing global clinical supply chains are unlikely to reverse in the near term. Volatility, regionalization, and resource competition are becoming defining features of the operating landscape rather than temporary disruptions.

By embedding flexibility, risk awareness, and continuous reassessment into clinical supply planning, organizations can adapt to this new paradigm without overhauling their entire operating models. In an environment where uncertainty is structural, resilience is no longer a secondary objective — it is a core requirement for successful clinical supply execution.

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