Optimizing Clinical Trial Supply Chains For Epidemic Response

By Chana Rabiner. Ph.D.

Epidemics question and test all assumptions important for traditional clinical trial supply chain management. During epidemics, demand can spike overnight, the epidemiology can shift unpredictably, and regulatory requirements may change or evolve rapidly. Under these conditions, traditional supply chain management struggles to deliver routine clinical products on time and with any reliability, much less those needed for clinical trials.

These struggles affect clinical research in two ways. First, trials that were already underway before the outbreak often need to and should continue. This protects participant safety and preserves data integrity. Second, at the same time, epidemics frequently require rapid initiation of new studies to understand disease patterns, evaluate diagnostics, or test potential treatments and vaccines. Both situations draw on the same underlying supply infrastructure. Regulatory authorities do recognize that public health emergencies can disrupt clinical trials and therefore expect sponsors to plan for continuity and participant protection.¹

Epidemic response supply chain management needs to change fundamentally, moving from reactive supply chain execution that is parallel to existing systems to an anticipatory supply chain design that builds upon and is integrated into routine supply chain. Supply chains must be able to absorb all these uncertainties, redirect resources, and deliver clinical trial products under extreme time constraints.

The Epidemic Supply Chain Constraint

Epidemic response environments typically have three interdependent constraints. First, speed and uncertainty control decision-making since the epidemiology of an outbreak may change daily. Second, clinical trial supply chains face resource scarcity as product, cold chain capacity, transport, and warehousing are shared across public health and humanitarian responses.² Third, data visibility gaps hinder the alignment of clinical trial supplies with site needs in real time.

Supply chain analyses taken from COVID-19 documented predictable patterns under epidemic conditions, including transportation disruptions, labor and capacity shortages, and heightened demand uncertainty.² For clinical trials, this translates into longer and unpredictable transit times, reduced availability of temperature-controlled services, and increased stress on sites to manage inventory.

Preparation Versus Reaction

Pre-Epidemic Playbooks

Preparedness is less about having a comprehensive plan and more about having realistic options that can be activated quickly. This begins with the development of a modular supply chain playbook, predicated upon various epidemic models and patterns. These include predefined clinical trial distribution pathways, surge logistics contracts, and pre-negotiated customs facilitation mechanisms.

Guidance on managing trials during major disruptions stresses anticipating changes to distribution, documentation, and site operations rather than responding to them ad hoc. For supply chains, this translates into taking advance decisions about alternative shipment routes, temporary storage arrangements, and communication processes that can be implemented without having to negotiate or renegotiate the basics during an emergency.¹

In practical terms, a playbook might specify that if a country imposes movement restrictions affecting courier operations, shipments shift from direct site delivery to delivery through a regional distribution center with documented local distribution support. It may also define when emergency relabeling is permissible at the regional distribution level rather than waiting for centralized packaging, provided quality approval pathways are clear. Having those contingencies reviewed and approved prior to an outbreak avoids losing critical days while teams debate options.

Dynamic Forecasting

Traditional forecasting approaches are inadequate during an epidemic response. Enrollment patterns are often driven by event rates and site activation timing rather than having a steady recruitment. Effective clinical trial epidemic response models must incorporate epidemiology and dynamic demand forecasting and then be updated frequently.

The World Health Organization (WHO) emphasizes the need for clinical trial systems that can remain functional and pivot during emergencies and pandemics.³ In practice, this means distinguishing between supplies needed to maintain dosing and supplies for participants already enrolled and those needed to support new or expanding sites and revisiting those assumptions regularly.

Activatable SOPs

Standard operating procedures are critical when a disruption occurs. They allow decisions to be made quickly without compromising compliance. Procedures covering labeling changes, import documentation, temperature excursion assessment, and emergency resupply should be designed with flexibility in mind and reviewed regularly.

Template SOPs for accelerated labeling, import authorizations, and emergency regulatory pathways should be maintained and periodically updated. Sponsors should also ensure investigational products are packaged and stored to prevent unacceptable degradation during transport and storage, as with Good Clinical Practice requirements since those don’t go away during an epidemic.⁴

Infrastructure Built For Surge Capacity

Epidemic conditions expose weaknesses in infrastructure that have been optimized for efficiency rather than resilience. Reliance on a single central warehouse or distribution center, limited courier options, or one shipment route increases vulnerability when disruptions occur.

Epidemic response requires infrastructure that is flexible and redundant. Regional hubs that have backup power, cold storage that is appropriate for different modes of travel, and the ability to split inventory capacity over multiple zones reduce reliance on long, unstable supply routes. Visibility systems need similar redundancy. Digital dashboards that integrate inventory, temperature, and shipment status from all partners provide a single operational view, even when local connectivity is limited.

Cross-Sector Coordination

Clinical trial supply chains don’t operate in isolation or as linear systems. They intersect with sponsors, contract research organizations, clinical operations, public health agencies, nongovernmental organizations, and logistics providers. They all must operate within clearly defined coordination frameworks. Daily standups with key stakeholders during surges help resolve bottlenecks early and prevent duplicate efforts.

Guidance on coordinated research and development during outbreaks underscores the importance of aligning trial activation, regulatory processes, and material movement so that evidence generation is not delayed by avoidable sequencing gaps.⁵ For supply chains, this coordination is most effective when it focuses on shared constraints such as customs processes, cold chain limitations, and warehousing capacity.

Metrics For Adaptive Performance

Epidemic response success is best measured by adaptability rather than standard fulfillment metrics, as those KPIs often mask what’s happening in real time. Useful indicators include time from outbreak detection to patient diagnosis to first patient dose, forecast variance between projected and actual consumption, and adaptation velocity, defined as the time required to pivot supply plans in reaction to new epidemiological data.

For example, tracking the number of days between site activation and investigational product available on-site for first patient dosing can reveal whether delays are happening in packaging, release documentation, shipment booking, customs clearance, or site receipt and reconciliation.

Lessons From Recent Epidemics

Recent epidemics show that flexibility is superior to rigid control. Organizations with consistent data standards, flexible inventory management systems, and clear decision pathways were better able to redirect supplies and support new studies without destabilizing ongoing trials. In practice, this meant buffer stock strategies based on confidence intervals were adapted more readily to changing demand or variability than fixed surplus approaches.

The COVID-19 pandemic provides the clearest documented example of how clinical trial supply models were forced to adapt under sustained global disruption. This started with regulatory authorities, including the U.S. FDA, issuing guidance explicitly permitting alternative approaches to investigational product distribution, remote monitoring, and modified documentation pathways to maintain participant safety and allow trials to continue.¹ This regulatory flexibility enabled sponsors to implement direct-to-patient shipment models and alternative site distribution strategies that were previously limited or restricted in many jurisdictions.

In parallel, during the early COVID-19 months of 2020, global passenger flight suspensions reduced cargo capacity and extended transit times for temperature-controlled investigational product and commodity shipments.² Sponsors responded by rerouting shipments through alternate distribution centers, revalidating passive shipping durations (including testing the shipper under extended duration scenarios), and increasing reliance on active temperature-controlled containers for extended transit windows. Together with the FDA regulatory guidance permitting direct-to-patient shipment in defined circumstances, these measures allowed trials to proceed despite severe transport constraints.

In addition, industry analyses following COVID-19 reflect a shift toward greater visibility. Supply chain teams reported increased use of technology-enabled visibility and decentralized approaches across the clinical trial chain following COVID-19.⁶

Conclusion

Clinical trial supply chains play a critical role during epidemics by supporting both the continuity of existing studies and the rapid initiation of new research. Achieving this requires preparation that emphasizes flexibility, clear decision-making, and realistic assumptions about disruption. Clinical trial supply chain management that includes epidemic readiness is no longer a niche skill anymore. It is a fundamental requirement for the modern world of clinical development. Supply systems designed to adapt, rather than simply endure, are better positioned to protect participants, preserve data integrity, and ensure that evidence generation keeps pace with the demands of an epidemic response.

References

1. U.S. Food and Drug Administration (FDA). (2023). Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies. FDA. https://www.fda.gov/media/172258/download
2. Queiroz, M. M., Ivanov, D., Dolgui, A., & Fosso Wamba, S. (2022). Impacts of epidemic outbreaks on supply chains: Mapping a research agenda amid the COVID-19 pandemic through a structured literature review. Annals of Operations Research, 319(1), 1159–1196. https://doi.org/10.1007/s10479-020-03685-7
3. World Health Organization. (2024). Guidance for Best Practices for Clinical Trials. World Health Organization. https://iris.who.int/handle/10665/378782
4. International Council for Harmonisation (ICH). (2025). Guideline for Good Clinical Practice E6(R3) (Final version). ICH. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_
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5. World Health Organization. (2016). An R&D Blueprint for Action to Prevent Epidemics. World Health Organization. https://cdn.who.int/media/docs/default-source/blue-print/an-randd-blueprint-for-action-to-prevent-epidemics.pdf
6. Clinical Trials Arena. (2024). Four Key Trends in the Clinical Trial Supply Chain. Clinical Trials Arena. https://www.clinicaltrialsarena.com/sponsored/four-key-trends-in-the-clinical-trial-supply-chain/

About The Author:

Chana Rabiner, Ph.D., is a global health and life sciences strategist with experience spanning diagnostics, infectious diseases, and global product implementation. Her work has focused on connecting scientific research, product development, and market strategy, with designing and scaling diagnostics, supply chain, and epidemic preparedness initiatives across more than 20 countries. She advises life sciences, biotech, and health technology organizations on R&D prioritization, regulatory strategy, and commercialization planning, with a focus on translating technical innovation into practical, real-world impact.