Clinical Supply Chain Continuity And Resilience

A conversation with Eugene Schneller, Ph.D., Professor and Dean’s Council of 100 Distinguished Scholar, NASPO Department of Supply Chain Management in the W.P. Carey School of Business at Arizona State University

As clinical trials become more global, decentralized, and dependent on complex supplier networks, business continuity in clinical supply can no longer be treated as a peripheral operational issue. It must be viewed as a core strategic capability tied directly to patient continuity, trial integrity, regulatory compliance, and enterprise value. Unlike traditional commercial supply chains, clinical supply chains operate under conditions of extreme demand uncertainty, high product specificity, strict regulatory constraints, and potentially irreversible consequences when supply fails. These conditions require a distinct approach to resilience — one that integrates forecasting, inventory strategy, supplier risk assessment, business impact analysis, and operational response within a unified continuity framework capable of maintaining patient dosing continuity and trial execution during disruptions. The challenge is further intensified by both man-made disruptions, such as trade restrictions and political conflict, and natural disasters.

In this Q&A, Elizabeth Urbanek, executive editor of Clinical Supply Leader, speaks with Eugene Schneller, Ph.D., about the key issues organizations must address to strengthen clinical supply chain resilience. The discussion draws on his scrutiny of the growing academic literature on business continuity, insights from the work at CAPS Research and the Supply Chain Resilience Center in the NASPO Department of Supply Chain Management at the W.P. Carey School of Business at Arizona State University, and ongoing curriculum development for the forthcoming certificate program offered by ASU in collaboration with the Disaster Recovery Institute International. Together, these sources support viewing clinical supply continuity as a strategic operating system for managing uncertainty, protecting patient treatment continuity, and preserving trial integrity — not simply as a compliance-driven business continuity plan.

1. Where do business continuity plans succeed or fail during an active clinical study disruption?

Business continuity discussions often emphasize documentation and governance more than operational execution. In practice, continuity succeeds or fails at key decision points: recognizing activation triggers, allocating limited inventory, validating alternate sourcing, accelerating quality and regulatory approvals, and coordinating escalation across functions. Robert Wiedmer and Adegoke Oke at CAPS Research at Arizona State University, drawing on cross-sector evidence, found that the most effective organizations multisource critical materials, maintain buffer stock, qualify backup suppliers, and screen suppliers early (https://capsresearch.org/). Equally important, they address capability gaps through employee training and supplier risk assessment so that investments strengthen both continuity and overall risk management maturity.

2. How can organizations build resilience into clinical supply chains without adding excessive waste, overproduction, or complexity?

Clinical supply teams must constantly balance speed, cost, inventory risk, and patient continuity. Unlike in many other industries, overproduction can lead to irreversible product destruction, while underproduction can jeopardize patients and undermine protocol execution. Sponsors can strengthen resilience through strategic inventory placement, rolling forecasts, safety stock policies, alternate sourcing, and the use of AI and simulation tools to support better decisions. At the same time, resilience carries real costs, and those costs are not always fully recognized or budgeted.

3. What vulnerabilities in clinical supply continuity planning are most often overlooked?

Many continuity failures stem not only from supplier disruptions but also from hidden dependencies and planning assumptions that surface only after a trial is underway. Enrollment volatility, comparator shortages, unseen Tier 2 and Tier 3 dependencies, decentralized trial logistics, and slow cross-functional decision-making often cause breakdowns despite formal continuity plans. Organizations therefore need stronger methods for identifying the vulnerabilities most likely to be underestimated. Working with a supply chain risk and resilience management firm can be a prudent way to monitor the complex supplier networks associated with any given trial.

4. How should sponsors rethink risk management for modern clinical trials?

Traditional supply risk models often assume a linear flow from suppliers to depot to site. Modern clinical trials involve decentralized models, direct-to-patient distribution, temperature-sensitive biologics, sourcing constraints, digital logistics platforms, and country-specific regulatory requirements. Trial sponsors should redesign risk management frameworks to reflect dependency mapping, participant continuity, and dynamic business impact rather than relying only on conventional supplier risk assessments.

5. What distinguishes organizations that recover quickly from supply disruptions from those that struggle for weeks or months?

Some organizations restore continuity quickly, while others remain stuck in prolonged disruption despite having formal plans. In many cases, the difference lies not in inventory volume but in decision speed, clarity of authority, pre-approved exception pathways, and executable playbooks. The resilience model developed by the Supply Chain Resilience Initiative at Arizona State University (https://supplychainresilience.wpcarey.asu.edu/) takes an all-hazards approach, combining research and training with the Disaster Recovery Institute International to help organizations prepare for recurring disruptions as well as infrequent, high-impact “black swan” events.

Because disruptions can also create opportunities for innovation, learning, and organizational change, organizations that absorb lessons from past events and build preparedness and implementation capability into their core competencies are best positioned to flourish.

6. How should clinical supply systems evolve in the face of real-world operational constraints?

Many continuity plans appear robust on paper but fail when faced with enrollment volatility, supplier qualification delays, forecasting errors, partial supplier recovery, quality holds, regulatory bottlenecks, and visibility gaps in digital systems. Tabletop exercises and validation efforts often show that theoretical resilience does not translate into executable response. The COVID-19 pandemic highlighted additional pressures, including chaotic trial proliferation, recruitment and retention challenges, difficulties in monitoring and supporting patients, and broader supply chain disruptions. At the same time, it accelerated the use of decentralized trials, remote monitoring, and telemedicine to maintain continuity. Organizations should use such disruptions as opportunities to learn, adapt, and evolve.

7. Why is clinical supply continuity fundamentally different from business continuity in other industries, and which resilience principles remain universal?

Clinical supply chains differ because disruptions directly affect patient treatment, regulatory flexibility is limited, inventory destruction is common, demand becomes clearer only during execution, and ingredient substitution is often not possible. Yet the core principles of resilience — visibility, optionality, time-to-survive, time-to-recovery, and decision discipline — remain consistent across sectors, including manufacturing, energy, transportation, and healthcare.

Sources and Further Learning: These references reinforce the central argument that clinical supply continuity should be treated as a strategic operating system for managing uncertainty, protecting patient continuity, and preserving trial integrity, not merely as a compliance-driven business continuity plan.

• Ait Mbiriq, I. (2022). Remote Clinical Trials Operations: Supply Chain Management and Framework Development. Master’s Thesis, Massachusetts Institute of Technology.
• Chen, Y., et al. (2013). Integrated Planning and Operation of Clinical Trial Supply Chain System and Risk Pooling. Industrial & Engineering Chemistry Research, 52, 152–165.
• DRI International / ASU Supply Chain Resilience Course Materials (2026)
• Fleischhacker, A. J., Zhao, Y., & Dessouky, M. (2011). Planning for Demand Failure: A Dynamic Lot Size Model for Clinical Trial Supply Chains.
  European Journal of Operational Research, 211(2), 404–410.
• Loucks TL, Tyson C, Dorr D, Garovic VD, Hill J, McSwain SD, Radovick S, Sonnenberg FA, Weis JA, Brady KT. Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches. J Clin Transl Sci. 2021 Mar 8;5(1):e102. doi: 10.1017/cts.2021.19. PMID: 34192057; PMCID: PMC8185429.
• National Academies of Sciences, Engineering, and Medicine. (2022). Building Resilience into the Nation’s Medical Product Supply Chains. Washington, DC: The National Academies Press.
• Paul, A. L. (2025). Inventory, Forecasting, and Contracting: Key Supply Chain Interventions to Reduce Drug Shortages in U.S. Healthcare.
• Soni, S., & Patel, A. (2024). Review on Pharmaceutical Supply Chain Resilience: Strategies for Managing Disruptions and Ensuring Continuity.
  World Journal of Current Medical and Pharmaceutical Research, 6(3), 8–14.
• Stephen, G. (2025). Business Continuity and Risk Mitigation in the Pharmaceutical Industry: Strengthening Supply Chains for Pandemic Preparedness.
  International Journal of Scientific Research and Management, 13(2), 8398–8412.
• Wiedmer, R., & Oke, A. (2025). Business Continuity and Supply Assurance, CAPS Research. Arizona State University.
• Yang, W., & Zelbst, P. (2024). Enhancing Crisis Resilience in Healthcare Supply Chains: A Strategic and Tactical Framework for Crisis Management Readiness Assessment. Institute for Homeland Security, Sam Houston State University.

About The Expert:

Eugene Schneller, Ph.D., is Professor and Dean’s Council of 100 Distinguished Scholar in the NASPO Department of Supply Chain Management in the W.P. Carey School of Business at Arizona State University. He is Co-Director of the Supply Chain Resilience Initiative and Co-Director of the ASU-DRI International Supply Chain Resilience Course and Certification Eligibility Program, a joint initiative designed to prepare professionals to manage escalating global disruptions. He earned his Ph.D. from New York University and has held faculty positions at Union College in Schenectady and Duke University. His co-authored book, Strategic Management of the Healthcare Supply Chain, provides a foundational strategy for developing fully integrated supply chain organizations. He has consulted with domestic and global firms on the design, structure, and maturity of their supply chains. (https://search.asu.edu/profile/24008)