Clinical Supply Is Not A Fix-It Function. It's A Planning Function.

By Julia Hancock, senior supply chain manager and freelance clinical trial consultant

When a clinical team holds its first meeting to discuss the new clinical trial, clinical supply is often not represented. The assumption is that bringing a supply chain expert halfway through will be sufficient. This is a costly mistake that also causes crucial delays in achieving FPFV (first patient first visit) date.

As the critical first patient in date approaches, operational teams often begin to work in panic mode. Not because they have done something wrong, but because clinical supply was not embedded early enough, and now its role becomes largely focused on troubleshooting.

From a clinical supply perspective, many critical decisions are made during setup that directly determine whether a trial stays on timeline and within budget.

Drug Product Planning Starts Earlier Than Most Teams Think

Clinical supply works closely with CMC manufacturing to establish drug product (DP) availability, shelf life, and packaging needs. Often, the manufacturer cannot perform clinical packaging, and the drug product must be shipped to the packaging and labelling facility.

At this stage, clinical supply must assess whether the shipment is local or international, what documentation must accompany it, and whether permits are required.

Clinical supply also determines whether the drug product arrives in bulk or in a container suitable for clinical use, or whether repackaging will be required. I once came across a situation where the manufacturer applied a label on each bottle. But because a manufacturer’s label isn’t a clinical label, each label had to be removed before clinical labelling could begin, adding avoidable time and cost.

Forecasting And Overage Decisions Can Prevent Drug Product Shortages

There are many companies that offer forecasting solutions. In clinical trial supply, even the most advanced forecasting software system will never replace an experienced clinical supply manager. Only by applying their own expertise, as well as using the system, can clinical supply accurately forecast investigational product needs.

Overage calculations will vary significantly and are driven by clinical supply considerations, including the number of participating countries, depots, and sites, as well as the therapeutic area and drug presentation.   

Initial forecasting provides a high-level overview to support manufacturing sufficient drug product to initiate the trial.  From that point forward, forecasting becomes an ongoing clinical supply activity, shaped by protocol complexity and multiple real-life factors, including:

• Clinical site recruitment (some sites may recruit as planned, over-recruit, or fail to recruit at all) directly impacts supply demand and redistribution decisions.
• Patients not tolerating the prescribed dose may need to be down titrated to a lower dose. The clinical supply manager will need to anticipate the availability of multiple dose strengths at sites.
• Drug dispensation depending on patient’s weight can accelerate drug depletion at specific sites or regions.
• Temperature deviations at clinical sites, particularly in complex supply chains such as vaccine distribution to regions with unreliable power infrastructure, can cause shortages.
• Protocol amendments, which remain one of the most significant drivers of re-forecasting, often impact dispensation schedules, shelf-life assumptions, packaging, labelling, and expiry date relabelling strategies.

QP Release, Labels, And IXRS: Where Delays Are Usually Created

Clinical supply dedicates significant time to planning DP essentials such as packaging, labelling, release, Qualified Person (QP) release, depot-to-depot transfers, and IXRS setup. I remember being asked to assist on a trial where the first patient in Europe was expected in two weeks’ time, only to discover that there was no available drug product in Europe. The timelines for DP transfer, depot receipt, and inventory processing were all delayed, as QP release was underestimated.

When  QP release is outsourced to a vendor, it remains a clinical supply-led activity and must be closely managed.  Vendors have many clients, and QP release slots must be booked with them well in advance. Paperwork should always be provided ahead of the planned QP release, but submission does not always guarantee completion. An outsourced QP can request additional documentation at any point during the process. Proactive planning and continuous communication with the assigned QP are critical to keeping timelines intact.

I encounter expediting and escalation frequently in my daily work. In most cases, this is the result of clinical supply not being involved early enough in trial planning. Pushing vendors to expedite their processes is not the right way to operate. That is when the mistakes happen. Packaging and labelling timelines exist for a reason, and consistently operating in “expedite” mode increases the risk of human error. And of course, it increases the cost of the trial.

Even something as simple as not reviewing your country-specific clinical labels can cause delays. If the label is not created according local regulations, you risk not starting the trial in that country on time. And what if the incorrect label has been included in a booklet? Will you reprint the entire booklet or segregate part of drug product label for a single country? Both options are time-consuming and costly from a clinical supply perspective. Label review and regulatory alignment should be completed by clinical supply up front.

Knowing that an import license is required to import drug product into certain countries is crucial. Without it, you will delay the trial. Can you ship directly to sites, or do you need a depot or pass-through depot? These are clinical supply decisions that must be confirmed during country feasibility and planning.

When setting up the IXRS system, it is also essential to involve clinical supply.  They will ask critical questions of the provider, such as whether the system includes a reconciliation and destruction module. I have seen studies nearing completion where reconciliation was due, but no one asked about this module at the beginning. As a result, site personnel were forced to perform paper-based returns, creating avoidable operational burden at the end of the study. Clinical supply also defines supply parameters and buffer stock levels and participates in user acceptance testing to prevent downstream IXRS errors.

Planning Is The Difference Between Control And Crisis

In my experience, most expediting to get drug product to clinical sites can and should be avoided. Clinical supply identifies permit requirements during country selection, including timelines for approval and whether permits must be renewed annually or cover the full study duration. Please do not underestimate these “small” details. From a clinical supply standpoint, they may lead to trial delays and even patient withdrawal.

Selecting the appropriate shipping solution should also remain a clinical supply responsibility. Yes, a service provider can recommend a shipper and data logger, but they are not accountable for the clinical study requirements. With variable transit times and customs clearance delays, drug product is at risk if shipping decisions are made without clinical supply oversight. I once encountered a provider who recommended a shipper that was only qualified for three days for shipping between Europe and the U.S., despite the fact this type of shipment often exceeds that time frame.

Clinical supply should also review a Quality Technical Agreement (QTA) with vendors responsible for packaging, labelling, release, and distribution. This input becomes critical if issues arise during the trial.

Yes, the clinical supply manager will continue to oversee the trial, but the most critical phase remains trial planning. This is where clinical supply decisions protect timelines, control costs, and prevent avoidable downstream disruption.

 People often ask what the most part of being a clinical supply manager is. The reward comes from seeing complex clinical supply processes understood and respected across study teams. When colleagues begin to recognize the value clinical supply brings to a trial, it confirms that early planning truly makes the difference between control and crisis.

About The Author:

Julia Hancock is a senior clinical trial supplies professional with over 15 years of experience supporting global clinical trials across pharmaceuticals, medical devices, and cell and gene therapy. She has led end-to-end clinical supply strategy, including packaging and labelling, QP release, import and export activities, IRT/IXRS setup, and vendor oversight across multiple regions. Julia has held senior clinical supply roles supporting both sponsors and CRO environments.