From Crisis Response To Repeatable Resilience In Clinical Supply

By Jesse Schafer, MBA, executive director, Healthcare Industry Resilience Collaborative (HIRC)

Clinical supply resilience is no longer viewed as optional, but it is not yet routine.

Recent disruptions have made vulnerabilities in clinical trial supply chains unmistakable, with clinical trial supply representing one of the most disruption-sensitive examples. Yet many organizations still manage resilience episodically, activating extraordinary measures only when shortages, delays, or supplier failures emerge. The harder and more durable step is embedding resiliency and transparency into everyday procurement and supplier management decisions using standardized, auditable inputs.

Clinical trial supply offers a clear illustration of these risks. The underlying challenge requires a shift from reactive response to repeatable operational practice across clinical supply categories.

Making that transition requires more than awareness. It depends on shared expectations, credible signals of supplier capability, and governance mechanisms that allow risk to be identified and addressed before it affects trial timelines or patient safety.

What Clinical Supply Can Learn From Health System Resilience Planning

Where health systems have made progress toward repeatable resilience, the common thread has been operationalization. Rather than treating disruption as an exception, leading organizations integrate resilience expectations into sourcing, supplier management, and governance processes.

Those experiences point to practical lessons clinical supply leaders can apply as they move from reactive response toward sustained capability for investigational products and trial critical materials.

In response to this need, several industry-led efforts have emerged to help translate resilience expectations into operational practice. One example is the Healthcare Industry Resilience Collaborative (HIRC), which works with providers and suppliers to develop shared assessment frameworks, standardized evidence, and peer-driven governance models that can be applied across categories, including clinical supply.

Turn Expectations Into Deployable Signals

Resilience needs to be comparable and verifiable. Clinical supply teams benefit from structured assessments that translate supplier capability into evidence that can be reviewed alongside traditional criteria such as quality systems, regulatory readiness, and lead times.

Standardized summaries of operational risk, rather than narrative assurances, allow teams to evaluate suppliers consistently and make informed decisions when managing investigational products or trial materials with limited alternatives.

Build A Single Trusted Data Layer

Fragmented diligence creates blind spots. A shared supplier-controlled data environment can reduce redundant assessments while providing consistent visibility into operational risk domains that matter most for clinical trials and high-criticality clinical supply categories, including continuity planning, recovery time objectives, and capacity constraints.

When suppliers control their data and authorize its use for defined purposes, clinical teams gain reliable inputs without increasing administrative burden or compromising confidentiality.

Operationalize Through Governance And Measurement

Standards only matter when they are applied. Short, structured supplier conversations, prioritized remediation milestones, and a limited set of performance indicators make resilience actionable rather than aspirational.

In a clinical trial context these practices help teams proactively manage risks that could otherwise disrupt enrollment, delay milestones, or compromise continuity of investigational product supply.

Where resilience is being operationalized effectively, clinical supply teams treat risk evidence as a sourcing input, use shared data for visibility, and track remediation through routine performance reviews for trial critical categories.

Building Clinical Supply Resilience A Practical, Adoptable Blueprint

Embedding resilience into procurement does not require redesigning sourcing processes from scratch. Progress typically starts with a small number of standardized inputs and governance mechanisms that expand over time as comfort and adoption grow.

The following sequence reflects how clinical supply teams are beginning to operationalize resilience for investigational products and other trial critical materials, with lessons that can extend to broader clinical supply governance over time.

Step 1 Introduce Structured Resilience Disclosure Into RFXs

Begin by requesting standardized resilience disclosures as part of RFX responses. Initially used as a transparency input, this establishes a consistent signal that can be evaluated alongside quality, regulatory, and delivery criteria.

Some organizations leverage third-party assessments or industry frameworks to support this step, while others rely on internally defined standards. The key is consistency and auditability.

Step 2 Socialize and Weight Resilience in Sourcing Decisions

As internal familiarity grows, resilience can be incorporated into sourcing decisions as a scored element or as a gating criterion for high-risk categories.

Illustrative weighting, adjusted by trial complexity or patient impact, may fall in the 5 percent to 15 percent range. This allows teams to signal expectations without excluding suppliers prematurely and helps prioritize continuity across the trial life cycle, while reinforcing resilience expectations that benefit clinical supply overall.

Step 3 Use Assessment Summaries to Structure Supplier Conversations

Rather than treating assessments as static documents, use them to guide focused discussions with suppliers. Confirm priority findings, align on remediation focus areas, and establish a small number of milestones to revisit during quarterly business reviews.

For clinical supply teams, these conversations center on investigational products and trial critical materials, helping address potential continuity risks before they escalate into trial delays.

Step 4 Apply a Scalable Adoption Ladder

Not all suppliers will be equally mature. Allowing lighter weight entry paths for smaller or capacity constrained suppliers, while setting clearer expectations for those supporting high criticality trials, balances inclusivity with risk management.

This graduated approach protects trial timelines and patient safety without unnecessarily limiting the supplier ecosystem.

Why A Resilience Mindset Matters

A resilience mindset does not eliminate disruption. It changes how organizations prepare for and manage it.

Rather than relying on emergency measures when failures occur, resilience is built through repeatable capability. This includes standardized expectations, shared evidence, and routine governance applied before disruption emerges. When done well, clinical supply teams gain decision-ready inputs, can prioritize remediation where risk is highest, and can create clearer incentives for suppliers to invest in continuity over time.

It is important to be explicit about limits. Resilience assessments and shared data are decision inputs, not guarantees of future performance. They are most effective when used alongside contracts, audits, quality systems, and ongoing supplier management, not as substitutes for them.

Operationalizing Through Peers And Shared Practice

Because resilience and transparency depend on broad adoption, no single organization can operationalize them in isolation. Progress requires shared standards, consistent signals, and practical forums where providers and suppliers can test, refine, and normalize new approaches.

Collaboratives such as HIRC provide one mechanism for advancing this work by offering shared tools, peer forums, and repeatable signals that organizations can adapt to their own governance models. These efforts are most effective when they reinforce existing quality systems, regulatory oversight, and supplier management practices rather than replacing them.

Practical Call To Action

For clinical supply teams seeking to move from awareness to adoption:

• Assign clear executive ownership for resilience as a procurement and continuity of trial priority.
• Memorialize weighting for resilience and transparency in strategic sourcing, calibrated by trial critical category risk.
• Standardize inputs by requiring structured resilience disclosures and assessment summaries as routine components of supplier management.

Resilience becomes durable only when it is embedded in how sourcing and supplier relationships are managed day to day, not introduced ad hoc during the next disruption. For clinical trial supply, this approach supports continuity of investigational products, protects patient safety, and helps trials stay on track.

About The Author:

Jesse Schafer, MBA, is executive director of HIRC, advancing procurement-ready resiliency standards, member programs, and partnerships across U.S. healthcare supply chains.

Disclosure

This article was drafted with assistance from generative AI and reviewed and edited by the author, who takes full responsibility for its content.