What Clinical Wishes Supply Did Better – And How To Close The Gap: Part 3 – Staying Aligned in a Moving System
By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader
Even when planning is solid, which we explored in detail in part 2 of this series, execution doesn’t happen in a static environment. Enrollment changes. Sites overperform or lag. Timelines shift. So as trials evolve, alignment between clinical operations and supply becomes critical.
“In order for the supply chain to keep up, it needs to have real-time data on enrollment and site activation,” says Elena (Ella) Sinclair, principal consultant at FlexPoint Bio – who served in clinical trial and operations management and director roles for five years at Sangamo Therapeutics after 17+ years in clinical research at UT Southwestern Medical Center. “If it doesn’t, you can guarantee there will be misalignment.”
Without that shared visibility, even well-designed supply strategies quickly fall out of sync with study reality.
The responsibility doesn’t sit with operations or supply alone. Clinical operations must provide the visibility. Supply must actively respond to it. Without that connection, issues compound quickly – and according to Sinclair, one key piece missing from clinical supply’s puzzle is “understanding the progression of the study.”
Another miss Sinclair highlights is, surprisingly enough, “working from the supply chain plan rather than from the protocol.” Perhaps this is because protocols are frequently amended. “Protocol amendments are not exceptions — they’re expected,” she emphasizes, explaining studies have multiple amendments, each with cascading effects.
“On average, I would say a single study will have three protocol amendments,” Sinclair continues. “In my experience, earlier phases tend to see more amendments, though the numbers vary considerably across therapeutic areas and trial designs. And I have seen studies with as many as 18 amendments. Each of those amendments may additionally have, on average, from seven to up to 10 different changes.”
And those changes are oftentimes not accounted for logistically. Changes can range from kits and IRT configurations, to new sites, new countries and even labeling. “That becomes a trickle-down effect, and it impacts how well we can perform in a particular study,” Sinclair explains.
The issue isn’t the change — it’s how well-prepared teams are for it. “It will come as no surprise, but again, one solution is to bring supply chain together with clinical operations at the planning stage,” Sinclair reiterates. “Put them together when the protocol is designed – and where the amendments are thought through. That allows for input from both about how decisions will actually work in real-time, at real sites, in real life.” She adds that it also gives the supply chain a bit of leeway to implement those changes.
The bottom line, per Sinclair, is ensuring the supply chain is involved in planning – and knowing exactly how different changes are going to impact the timeline. “Automatically, you should have a set of questions that comes up – sometimes that’s as simple as a very carefully designed checklist.”
For example: How are we bringing the supply to this particular country? Do we need to have a country or region-specific depot? Do we need to have a particular license? How long does it take?
“All of this – including changes in labels, changes in kits – all of this has to be lined up before the actual protocol amendment is signed,” Sinclair emphasizes. “And from conducting gap assessments, I can tell, based on which roles reviewed the document (or didn’t), what kinds of challenges particular amendments will have.”
Understanding Trial Goals: Clinical vs. Supply Metrics and End Users
Even when teams are aligned with intent, structural misalignment can still create friction. “Each function has its own metrics of success,” Sinclair notes. “And oftentimes those metrics are competing with each other.”
Clinical operations is measured by enrollment. “If you plan to enroll 50 patients and you enroll 60 — you’re doing great.” On the other hand, supply chain is measured by inventory. “You don’t want to produce too much of a particular drug that will sit there and go past expiry,” says Sinclair.
In practice, those KPI goals don’t align – and often work against each other. So, it’s not about pointing fingers, it’s about understanding the systems in which both teams are operating. Until those incentives are better aligned, friction between functions is not just likely — it’s structural.
In addition, both clinical operations and supply operate under constant urgency. “Everything has to be done yesterday,” Sinclair says. But speed comes at a cost. “When you do that, you absolutely guarantee that you will miss something,” she says. “And you’re certainly not thinking with the end user in mind.”
That’s a shared challenge. Rushing early decisions often creates problems that are harder — and more expensive — to fix later.
Why Isn’t Clinical Supply Brought Earlier to the Table?
This brings us back to the original question: if early involvement is so critical, why isn’t it happening?
“It should be a no-brainer,” Sinclair says. “But there are many different reasons. One of the most common excuses I hear is we have our own core team, and we don’t want to have too many people at the table – because it becomes more challenging when you reach a decision point and have 10 people versus five.”
Sinclair adds that the expectation is for those who are at the table to disseminate the key decisions or ideas to the right people. “But oftentimes, it doesn't happen because you just don't know that supply chain needs to know, ‘Hey we just selected China as our next point for site activation. And we want to start enrolling in the next 12 months.’”
This becomes a problem because, as readers know (all too well), to start activating sites, drug must be delivered to them. And customs and export documentation is required.
“And if you want to bring drug into the UK, for example, you need to have a qualifying person who is residing there who signs off on it. It sounds like an easy thing to do, but I’ve seen it take months to find that person,” Sinclair explains.
According to Sinclair, clinical supply experts are more attuned to the limitations of shipping lines to those sites, the types of documentation necessary, and differences if you have small molecules versus biologics and gene therapies. “Because different entities need to get the stamp of approval in different countries.”
Sinclair adds: “You don’t know what you don’t know. So, when you bring more people into the conversation, you increase your chances that somebody at the table will have thought of that or had that experience.”
Another reason is the lack of awareness. “The organizers may not be aware that it is critical to bring clinical supply to the table,” Sinclair observes. “It’s an old-time mentality that unfortunately, is very present – both clinical operations and clinical supply are often viewed simply as the execution arm.”
A Shift in Mindset, Not Just Process
Taken together, there are two changes Sinclair would prioritize, and they aren’t complex — but they are transformational. First is a shift in mindset. “I would shift the clinical team’s view of supply chain from mere execution to planning, making the supply chain an intrinsic part of planning — from protocol concept to any amendments.”
On the surface, that seems straightforward. In reality, it means rethinking how teams are structured, when supply is brought into discussions, and how decisions are actually made.
Second is designing with the end user in mind. “I would love to see everything that is externally facing, such as at the site, designed with the end user in mind,” says Sinclair. From packaging, to scheduling, to the complexity of how a particular specimen is processed.”
At its core, that’s about reality over theory. Designing not for internal workflows, but for the coordinators, patients, and clinicians who are executing the trial in real time — often under pressure and with limited bandwidth. Because ultimately, this isn’t just about bringing clinical supply to the table earlier. It’s about what changes when they’re there from the start.
If there’s a single takeaway across these three discussions, it’s this: most clinical supply issues aren’t surprises — they’re consequences. Consequences of when supply is brought in (too late), how assumptions go unchallenged, and how loosely teams stay aligned as trials evolve.
The solution isn’t more process, it’s better integration of thinking upfront. Because when supply is treated not as an execution function, but as a strategic partner, many of the issues that surface downstream are addressed before they ever take shape.
