What Clinical Wishes Supply Did Better – And How To Close The Gap: Part 1 – The Cost Of Late Involvement
By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader
In this article series, I’m crossing the line — going to the “other side,” if you will — but for good reason.
For the past few months, I’ve immersed myself in all things “clinical supply” to understand where it fits into the drug development process. During that time, I’ve heard a consistent lament: We’re invisible. An afterthought. Clinical operations should include us earlier.
From what I’ve seen, it’s a fair complaint. But there are three sides to every story – yours, mine, and the truth somewhere in the middle. So, I reached out to industry expert Elena (Ella) Sinclair, principal consultant at FlexPoint Bio, to get a clinical operations view of the clinical supply role – and what it wishes we did “better.”
Sinclair consults for small biotech companies and startups, focusing on operational strategy and logistics, clinical vendor outsourcing, and clinical quality assurance. She’s held various leadership roles, including as CEO and co-founder of the Life Science & Tech Consultants Association, and as both Seattle Chapter Chair of the membership committee and board member for the Women in Bio organization.
Sinclair also 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. Here, she dons her clinical operations hat to give us the “opposing” view of clinical supply.
In fairness, her views are less about what clinical supply could “do better” and more about how both sides – clinical operations and clinical supply – could work better together. For example, if a trial goes awry, the site is usually the first to feel the impact in the form of delayed visits, confused coordinators, missed windows, or patients waiting longer than they should. But these issues don’t exist in a vacuum.
“That work is intrinsically dependent on what kind of planning was done… on the decisions that were made earlier,” Sinclair says. And those decisions are rarely owned by just one group.
In practice, that shared responsibility shows up most clearly in when — and how — clinical supply is brought into the process.
Involve Clinical Supply Early to Ensure Drug Continuity
One of the clearest places this breaks down is in timing. “The number one challenge,” Sinclair says, “is when you have a site active, and there’s no investigational product.” She explains that clinical operations spends months activating sites, training staff, and lining up participants. So when no drug arrives “that’s a significant failure.”
But that kind of breakdown doesn’t start at the site. It starts earlier. “The mindset is still that supply chain is an execution arm — here is the protocol, go and do it,” Sinclair explains. That framing sets teams up to react to problems rather than shape them; often when the cost of change is already high.
Such a late handoff perpetuates problems ranging from mere headaches to true tragedies. “When things break down, they can be as benign as a postponed visit to as catastrophic as risking patient safety,” Sinclair continues. While she reports that most people are understanding when occasional postponements happen, if these issues become more prolonged or more frequent, you can miss a protocol window – which can be very tight. “Sometimes, plus or minus three days,” she highlights.
Furthermore, every time you miss a window, this is a protocol deviation – and immediately regulatory non-compliant.
“It's tracked. It's reported to the FDA, for example, and then it becomes a potential cause for a warning letter. In my experience, approximately 30% or more of warning letters come from not following protocol,” Sinclair notes.
But timing issues rarely exist on their own. When they do arise, it’s how they’re communicated that often determines how much impact they actually have.
Communicate Clinical Supply Issues Quickly — And Bring Answers
When supply challenges arise, communication becomes crucial. “Early warning… is critical,” Sinclair says, adding that from the clinical operations side, the biggest issue often isn’t the problem itself; it’s finding out late or without context.
But communication gaps are rarely one-sided – and the expectation is shared clarity. “That way, everybody knows. Everybody’s aware,” Sinclair explains.
Common communication channels range from informal tools like email, spreadsheets, and ad hoc calls — often quick but prone to fragmentation — to more structured platforms such as IRT/RTSM systems and real-time dashboards that support coordination and visibility. Teams also rely on collaborative spaces like messaging groups and dedicated planning meetings to surface issues, align stakeholders, and drive decisions more effectively.
In addition, when issues are communicated, they need to come with direction. “Don’t just say there’s a problem — bring a solution,” Sinclair advises. That might mean expedited shipping, adjusted schedules, or alternative approaches.
She underscores: “Explain it will cost X in addition to the plan. Or that an unavoidable issue has come up and the plan needs to be pushed to a later date. ‘We’re taking a hit, … but this is what we're going to do to prevent it in the future.’” And just as importantly, give a root cause analysis, Sinclair suggests. “We’re all humans and we appreciate that.”
So, when clinical supply issues hit, it comes down to three key actions, per Sinclair: “early warning, proactive communication, and being very transparent.” In practice, this means moving beyond passive updates to defined escalation paths and a clearer ownership of decisions.
What all of this points to is simple: When supply is brought in late, the issues that show up at the site level are often already set in motion. And by then, they’re much more difficult — and more expensive — to fix.
