When Disruption Becomes the Default in the Clinical Trial Supply Chain: Q&A with Hal Green, Loftware

With geopolitical instability—from the Iran conflict to broader regional disruptions reshaping global trade routes and manufacturing dependencies—now a baseline condition rather than an exceptional event, clinical supply chains built for stability are being stress-tested in ways they were never designed to handle.

To explore this further, Applied Clinical Trials spoke with Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, about where fragmented systems are most likely to fail, how labeling errors cascade into patient safety risks, and what a genuinely resilient clinical supply chain infrastructure looks like in practice.

ACT: How has supply chain fragmentation in clinical trials evolved from an efficiency problem into a resilience problem?

Green: That's a great question, and you're right. For a long time, fragmentation has been about efficiencies—where we can improve them, where it slowed down trials but didn't necessarily stop them. What's changed is really the level of volatility and complexity in clinical supply chains in particular.

Trials have become more global, more adaptive, more decentralized, and far less predictable. The fundamental question from sponsors has shifted from "can we run this trial" to "can we run this trial while absorbing impact and maintaining continuity?" That's where resilience has come into it.

One big question we see is how fragmented a customer's data is. In a supply chain with fragmented product and labeling data, these environments can become really brittle. We want to keep them ductile and adaptable. Even small changes—changing the size of a font, for example, or a manual rework or protocol amendment—can propagate and cascade and eventually become trial interruptions. What we're trying to do with customers is not just enable the ability to make changes, but to do it without affecting trial continuity. Because they're more global, they're more exposed to disruption, and we're working with them to build resilience to that disruption.

ACT: What are the most common points of failure when sponsors and CMOs are still relying on disconnected systems to manage product and compliance data?

Green: That question segues nicely from the first. A lot of these legacy systems were very manual when they came about, and I often use the analogy of an archipelago of islands with customers. These islands are your silos—not just of data, but of people. What we're trying to do is bridge those islands so that you end up with a contiguous continent.

If we continue with that analogy, between those islands you have ships carrying change. If you have a small change, it's often very manual. And where you have disconnections between people and systems, the biggest failures tend to happen at the handoff. You have a trigger for a change, it gets handed off to the system, and then you end up with version drift—people working on different versions of different sources of product data. This then cascades, introducing delays and latency.

The scariest part of these failures is the lack of real-time visibility. With that island analogy, you can't quite see what's going on in the island over there. When you don't have a connected supply chain or connected people, you end up with failures that fragmentation hides until it becomes operationally painful. I often ask customers when they first noticed an issue, and they say they noticed it when the impact happened—not when the change itself occurred.

This isn't just minor disruption. It affects traceability, compliance, authenticity. We want these issues to surface before things are already in production, not after. We want to mitigate ahead of time and connect people and systems so that these handoffs are better managed.

ACT: How do labeling and documentation errors propagate through a fragmented supply chain, and what does that mean for trial continuity and patient safety?

Green: Very small changes can trigger a cascade. One example from a customer: they wanted to change the font size on a container label. To make that change, they had to go to a third party, work from a disconnected data source, get it approved through multiple cycles—and that small change kept propagating through the supply chain.

When the error is an actual mistake rather than just a change—an outdated text element, a missed protocol amendment, a new country-specific regulatory requirement—these errors get copied rather than corrected in fragmented environments. And again, you don't notice it until it's too late. What starts as a small label rework or a bit of missing data moves through the supply chain and ends up with quarantined shipments, re-labeling, and delays.

This ultimately isn't just an operational delay. It affects trial timelines. It affects trust. And for me, that's the scariest part for customers, because that trust isn't just between themselves and their partners—it's between the patient and the regulator. Patients and regulators expect absolute confidence that they're getting the right products at the right time. That confidence erodes in fragmented systems.

Connecting data isn't just about reducing errors. It's about containing them. We have to assume that chaos can't always be fully mitigated—it's going to occur—and we need to be able to contain it and manage it at the right time with the right tools in place.

ACT: How are geopolitical instability and regional disruptions increasingly factoring into how sponsors think about supply chain risk and contingency planning?

Green: This is a very salient topic. We're facing unrivaled levels of geopolitical and regional disruption across all industries. But tying this into the clinical supply chain, I think it really all comes down to planning.

Some time ago, chaos or disruption was seen as an exceptional event. We now expect it, and I think that's a good thing—it's changing how we plan. That shift has taken a lot of sponsors and others in the industry to step back and really assess how resilient their supply chains actually are. Many of these systems and processes were built for stability. And when you're still relying on manual spreadsheets, manual emails, and copies of data, a fragmented supply chain can absorb an impact slowly because of how disconnected and clunky the environment already is. But that doesn't mean it's resilient.

Sponsors are starting to think about optionality—the ability to redirect supply chains, update compliant materials, and maintain oversight. That goes back to visibility. If you have real-time visibility, you can better manage and rebuild processes every time a change happens, and condition to that change.

Going back to the archipelago analogy—if those systems are connected, even if one island gets disconnected, the rest of your archipelago is better positioned to adapt. Compliant materials that are impacted can be approved and deployed centrally without rebuilding every single process each time a disruption occurs.

ACT: What does a more resilient clinical supply chain infrastructure actually look like, and how far is the industry from getting there?

Green: We hear a lot of buzzwords—cloud connectivity, de-risking, resilience—but what does it actually look like in reality? I think we have to focus on enablement, not just buzzwords.

To enable a clinical supply chain to be resilient, you have to think about not just systems but people. You can have all the resilient systems in the world, but if the people in place aren't able to leverage them, you won't be able to support collaboration at scale. A resilient supply chain is often described as something that is traceable, authentic, compliant, and deployable at scale. That applies to people too—they need to be able to respond rapidly to change, and they need the right tools in place to do that.

The industry is on this path. They know where the final destination is, but the question is how to get there. I think resilience now matters as much as compliance. And somewhat controversially, resilience and continuity may deserve to be an order of prioritization above compliance, because if you're not resilient and your trial is disrupted, that will impact compliance anyway. The two are interconnected.

A big topic at a recent GCSG event was patient adherence. If there is a disruption in supply, or if there's incorrect information for whatever reason, that erodes trust and erodes patient adherence in these trials. So resilience isn't just a buzzword—it's an enabler of compliance, trust, authenticity, and traceability. The building blocks are interconnected systems and interconnected people working from a single source of truth that can adapt to change.

Editor's note: This Q&A is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.