Managing Risk And Resilience In Clinical Trial Supply And Operations

By Kevin Coker, JD, MPH, MS, innovation strategist MD Anderson Cancer Center

Clinical trials are now being executed in an environment where predictability can no longer be assumed. Cost volatility, supply disruption, and regulatory uncertainty are increasingly shaping how programs are designed, supplied, and governed. What were once manageable variables are now central drivers of operational risk.

Earlier in this series, I examined how tariffs are destabilizing clinical trial supply chains and how FDA staffing constraints are amplifying those pressures by slowing regulatory interaction and limiting flexibility. Together, these forces are shifting risk upstream, forcing sponsors and trial leaders to commit resources earlier and make decisions with less certainty.

(Editor's Note: You can read Part 1 here and Part 2 here.)

This final article focuses on how organizations can respond. I bring these dynamics together to examine practical approaches to managing risk across clinical supply and trial operations, building resilience into development plans, and strengthening governance and decision-making. The objective is not to eliminate uncertainty but to manage it deliberately while preserving trial continuity, execution quality, and patient access.

Where The Pressures Converge

The intersection of tariffs and FDA staffing constraints is where the impact is most tangible. Tariff-driven cost increases and customs delays push teams to commit inventory earlier and carry more risk. At the same time, limited regulatory bandwidth slows the approval of sourcing or manufacturing changes.

Drug sourcing strategies are shifting accordingly. Single-source dependencies — particularly for APIs, comparators, and sterile packaging components — are increasingly difficult to justify. Yet qualifying alternate suppliers requires regulatory documentation, analytical bridging, and often new stability data. When review capacity is constrained, these transitions take longer than planned.

Trial logistics are equally affected. Changes in sourcing ripple through shipping lanes, depot strategies, labeling, and site-level inventory management. Delays in one region can force staggered activation or uneven enrollment, increasing coordination burden on clinical operations teams and CROs and introducing variability that complicates execution.

Budgeting under these conditions becomes an exercise in scenario planning. Tariffs increase direct costs. Regulatory delays extend timelines, driving higher site fees, monitoring expenses, and internal resource demands. For investigator-initiated trials, the margin for absorbing these pressures is especially thin.

Adapting With Intent

In this environment, clinical supply strategy must be deliberate rather than reactive. Many of the tools we relied on historically — buffer inventory, expedited shipping, or last-minute regulatory engagement — are no longer sufficient on their own. What is required instead is earlier decision-making and a greater willingness to invest ahead of certainty.

Secondary and tertiary supplier qualification must begin far earlier in development programs, even when the probability of disruption appears low. For APIs, sterile fill/finish, and comparator drugs, optionality has become a strategic asset rather than an inefficiency. At MD Anderson, we increasingly scrutinize development plans for where single points of failure exist, not because disruption is guaranteed but because recovery timelines are now measured in quarters or years rather than weeks.

Scenario-based planning has also become essential. Supply chain models must now incorporate tariff escalation scenarios, customs delays, and regulatory review variability alongside traditional enrollment and demand forecasts. These models influence decisions about regional site activation, depot placement, and inventory commitment timing. In some cases, sponsors are reconsidering whether global simultaneity is realistic, opting instead for phased geographic rollout to manage risk.

Submission quality and regulatory strategy matter more than ever. Clear, well-supported filings reduce review friction and minimize iterative cycles that consume scarce agency bandwidth. Early engagement with the FDA, when feasible, helps surface issues before they become execution delays. In a constrained system, preparation directly translates into predictability.

Strategic, Operational, And Leadership Considerations

The pressures described also influence:

• Financial planning: Tariffs and delays erode fixed budgets and require scenario modeling. Organizations must consider contingency funding and dynamic resource allocation to absorb unexpected cost increases.
• Portfolio strategy: Programs with high operational risk may be deprioritized; global rollout may be staged. Sponsors should evaluate trade-offs between scientific priority and operational feasibility to make informed program decisions.
• Governance and accountability: Clear decision rights, escalation thresholds, and executive oversight are essential. Establishing formal escalation pathways ensures timely resolution of high-impact operational or regulatory issues.
• Human capital: Burnout risk increases for staff managing exception-driven workflows. Providing support, clarity on roles, and realistic timelines can help retain experienced staff and maintain operational quality.
• Patient impact: Delays affect eligibility, enrollment, and trust in clinical research. Maintaining transparent communication with investigators and sites can help mitigate patient risk and preserve confidence in the trial.

The pressures explored across this series, including tariff-driven supply volatility and FDA staffing constraints, are interconnected and cannot be addressed in isolation. Sponsors and clinical supply leaders must take a holistic approach that integrates supply chain strategy, regulatory planning, governance, and scenario-based decision-making. Investments in digital infrastructure, cross-functional alignment, and proactive communication are essential to anticipate challenges, reduce downstream risk, and maintain trial continuity.

Ultimately, managing these forces is about more than process or efficiency. It is about enabling timely patient access, protecting the integrity of clinical data, and supporting teams to make deliberate, informed decisions under uncertainty. By embracing resilience as a guiding principle, organizations can navigate the complexities of modern clinical development while maintaining ethical, operational, and strategic standards.

For sponsors, CROs, and trial leaders, the opportunity lies in turning these external pressures into a framework for smarter planning, stronger governance, and better patient outcomes. By proactively anticipating risk and embedding resilience into every stage of development, organizations can transform uncertainty into a competitive and ethical advantage. Comments, questions, and experiences from the field are always welcome.

About The Author:

Kevin Coker, JD, MPH, MS, is an Innovation strategist and leads MedTech development at MD Anderson Cancer Center, the world’s top-ranked cancer center, and advisor to First Bight Investments, a venture fund/accelerator for synthetic biology and industrial biomanufacturing. Coker co-founded and was CEO of Proxima Clinical Research, a CRO ranked by Inc. Magazine as one of the fastest-growing companies in 2021 and 2022, earning more than 30 awards in its first seven years. He also founded M1MedTech, a virtual venture studio for medical devices, and co-hosted Inventing Tomorrow podcast. Coker has held senior leadership roles across biotech, MedTech, and clinical research, including board director at Volumetric Biotechnologies (acquired by 3D Systems), CEO of MolecularMatch, VP at Worldwide Clinical Trials, and VP, US Oncology Research at McKesson Corp. He holds degrees in biology, pathology, law, and public health and is certified in clinical molecular biology and U.S. regulatory affairs.