Decision Authority And Direction — The Gap In Deviation Planning

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

To attenuate excursion risk and protect product integrity, clinical supply has taken advanced environmental control measures; from smarter packaging design and validated transport conditions to real-time visibility and monitoring across global cold chains. Within these systems, connected temperature loggers also flag excursions faster, more precisely, and more visibly than ever.

But when those alerts are triggered, many organizations still hesitate; not because they lack data — because the decision authority is unclear and the action pathways are not fully defined. That gap between detection and decision is where supply is delayed, risk compounds, and product availability becomes uncertain.

While it doesn’t close the gap (we’ll address this later in the article), the industry continues to invest in environmental controls and infrastructures that at least partially mitigate excursions and decrease risk. Case in point: a cross-dock container freight station (CFS) recently opened in Chicago.

Clinical Supply Cross-Docking to Minimize Handoffs – and Risk

The 78,000 square foot facility (~7,246 m²) — nearly three-quarters the size of a Manhattan city block, or five hockey rinks — includes a 5,200 ft² (~483 m²) dual temperature-controlled healthcare addition designed to “maintain end-to-end internal control over temperature-sensitive healthcare cargo.”

This focus on temperature control isn’t particularly novel. And the facility is certainly not the largest of its kind. But the cross-docking approach got me thinking.

Before diving in, it’s worth acknowledging: cross docking isn’t new. As many readers know, it’s been used for decades across industries to transfer products directly from inbound to outbound shipments, with minimal in-between storage. The goal is simple — streamline movement, reduce dwell time, and minimize storage costs.

It’s also not unique; in fact, the use of cross-docking is expanding. Precision Business Insights estimates the cross-docking services market reached US ~$2.52 billion in 2025, and projects this will climb to ~$3.79 billion by 2032 (a 6.0% CAGR). This is driven in part by lessons from the COVID-19 pandemic and the need for more flexible, resilient logistics networks.

What strikes me about cross docking is its design strategy to minimize handoffs. For most industries, it enables faster delivery — getting your Amazon shipment the next day (or sooner). For pharma, it additionally means controlling exchanges between handlers, which translates to fewer balls dropped — since, as Forslund highlights, cold-chain failures often emerge across fragmented networks between logistics providers, depots, and customs authorities.

Taken together, temperature control and cross docking should, in theory, provide end-to-end visibility and reduce risk. Case closed.

But theory doesn’t always hold up in practice, which raises the question: what happens when, despite all these efforts, something still goes wrong? You need an action plan – and as they say, a good offense is the best defense.

Clinical Supply’s Real Differentiator: Acting Under Uncertainty

In clinical supply, minimizing deviations like temperature excursions is important but success is ultimately defined by how effectively they are managed when they occur. That expectation has evolved over time.

Deviation control became legally enforceable under U.S. IND regulations in 1987 and later shifted toward risk-based oversight with the introduction of ICH E6(R2) in 2016. More recently, with the adoption of ICH E6(R3) in 2025, deviation readiness was explicitly codified as a proactive requirement.

Sponsors are now expected not just to respond to excursions and other deviations, but to define — before they occur — how those responses will be executed. In fact, the absence of a deviation readiness plan is viewed as noncompliance in the U.S.

At the same time, industry guidance increasingly emphasizes that as therapies become more temperature sensitive and supply chains more global, environmental control must be paired with mature, executable deviation-response planning.

When Detection Outpaces Decision

Across Clinical Supply Leader coverage, one pattern emerges consistently: sponsors are rarely underprepared when it comes to detecting temperature deviations. Sensors, loggers, and alert thresholds are increasingly sophisticated. The industry understands what is at stake — temperature excursions can compromise product quality, safety, and efficacy.

Where sponsors lag behind is in what happens next: how deviations are assessed, escalated, and ultimately decided. These actions are less clearly defined, which creates a gap that becomes readily apparent during real excursions, when data exists but authority does not.

To understand how this breakdown plays out in practice, I spoke with Eugene Suh, Co-Founder and Managing Principal of LTD Consulting, who advises biotech sponsors on global clinical supply execution. Suh spent more than 15 years leading clinical supply strategy from early phase through global studies at Genentech, Eli Lilly, PCI, and Edgewise Therapeutics before launching his consultancy in 2024.

“The biggest problem I often find is that sponsors haven't defined a process for reporting temperature excursions, and they haven't defined a clear set of roles and responsibilities for how to resolve temperature excursions,” Suh explains.

Ownership often defaults to QA — but not consistently.  “Roughly speaking, temperature excursions are often handled by QA,” he says. “But in some cases, supply managers can approve whether IP is acceptable for use if the deviation is within a set limit. This needs to be defined ahead of time through alignment between clinical supply and QA.”

Without that alignment, decisions stall — not because risk cannot be assessed, but because authority is unclear.

Where Decisions Break Down

The breakdown is often reinforced by inconsistent reporting pathways. Sites may be instructed to report excursions through pharmacy manuals, IRT systems, or other mechanisms — sometimes inconsistently within the same study.

“Sites can report via temperature excursion forms or through IRT,” Suh notes. “It’s important for the sponsor to define which system site personnel should use so there are no delays.”

Without that clarity, delays are inevitable.

“Temperature excursions are time-sensitive deviations that need to be resolved quickly to provide continued, uninterrupted drug product support to patients,” he adds. “When a process isn't defined ahead of time, it can lead to delays and potential out-of-drug situations.”

As deviations escalate into formal investigations, the bottleneck often shifts from reporting to ownership.

“When planning investigations, defining roles and responsibilities and aligning across sponsor functions and logistics teams are the elements most likely to cause delays if not clearly addressed,” Suh says.

The result is familiar: parallel reviews, repeated data requests, and delayed disposition decisions. Technology does not fail in these cases. Governance does.

Why Real-World Conditions Undermine Plans

Even when deviation response plans exist, they often falter under real-world conditions.

Global logistics introduces variability that static procedures cannot fully capture — from regional regulatory expectations to infrastructure limitations and environmental conditions.

“When designing deviation response plans, it’s important to identify the key pieces of information that can quickly determine whether IP is acceptable for use,” Suh explains. “Then define a clear communication path so the process remains practical and executable.”

Understanding how temperature data is generated and interpreted is equally critical.

“One recurring misunderstanding is how logistics partners physically place temperature loggers within a shipper,” Suh says. “That can influence readings and how excursions are perceived.”

For example, a logger placed near ice packs may register lower temperatures without necessarily reflecting product exposure.

More broadly, not all excursions are equal.

“Sponsors often assume any temperature deviation affects IP usability,” he notes. “But acceptable ranges and total time out of environment (TTOE) are typically defined in CMC stability data.”

Underlying all of this are the physical realities of shipping.

“Cross-docking, driver breaks, weather conditions — these are everyday factors that influence temperature performance and root cause assessments,” Suh adds.

Infrastructure can reduce exposure. It cannot eliminate variability.

What Effective Sponsors Do Differently

Across sponsors that consistently manage excursions without disrupting supply, one pattern stands out: success is not defined by avoiding deviations, but by being prepared to act when they occur.

“The key to preparedness is having clear, repeatable processes across the entire temperature excursion handling,” Suh says.

In practice, that includes:

• Clearly defined decision authority established in advance
• A single, unambiguous reporting pathway for sites
• Immediate access to stability data and shipment context
• Pre-aligned communication channels across QA, clinical supply, and logistics partners
• Workflows designed to function under time pressure or with incomplete information

While these plans don’t eliminate uncertainty, they support decision-making when supply teams are faced with it.

Control + Preparedness Defeats Deviations

While temperature control and cross docking measures can provide visibility and reduce risk, these measures alone don’t determine whether clinical supply continues or stalls. The preparedness of organizations – i.e., how they define authority, interpret risk, and act when facing deviations – is equally important. It takes the best of both; a good offense and a good defense.