How Just-in-Time Supply Can Reduce Waste and Control Costs: Early-Stage Biotechs, This One’s for You

Early-stage clinical trials can be like a balloon in a gust of wind: unpredictable. Even when everything goes according to plan, clinical trial supply planning for Phase I and II trials rarely moves in a straight line. Enrollment shifts. Protocols change. Sites activate at different speeds… 

When your supply model is built primarily around projected enrollment rather than actual site activity and patient demand, those shifts can quickly lead to wasted products, added costs, and unnecessary delays. Nobody wants that. 

Why enrollment uncertainty makes early-stage supply planning difficult

Perhaps you expect 10 sites to enroll, but only 3 do so quickly. With a traditional supply model, sponsors may allocate inventory across sites based on projected rather than demonstrated enrollment. That’s good, right? You’re protecting trial timelines and continuity of treatment by ensuring stock of everything you need… 

But what happens if products expire before they’re used?

Overstocking can feel like a safer option, but unused inventory still costs money. Overstocking leads to sponsors paying for the product, yes, but also for storage, temperature monitoring, inventory tracking, redistribution, expiry replacement, and eventual destruction if the product is never used. 

Just-in-time supply can reduce the need to overbuy upfront. Inventory may be held centrally or regionally and released based on predefined demand signals and safety-stock thresholds, typically managed through an IRT/RTSM system. Instead of distributing inventory everywhere “just in case,” sponsors can preserve budget by positioning and deploying products based on site activity and enrollment needs.  

This becomes especially important when products have shorter shelf lives or are expensive to replace. Every unused pack, kit, or vial sitting at a low-enrolling site creates risk. For high-cost comparators, conmeds, rescue medications, specialty products, or temperature-sensitive products, that risk can quickly become a budget bottleneck. 

And then there’s your protocol.

If dosing changes, cohorts expand, or conmed and rescue medication needs shift, large amounts of already packaged or distributed inventory may need to be relabeled, transferred, replaced, or destroyed. 

Keep your balloon tethered.

Remember that balloon in a gust of wind analogy from earlier? Just-in-time supply can act as your tether, giving sponsors more flexibility for when early-stage clinical trial requirements evolve or become unpredictable.  

Just-in-time supply saves you time and money, but only if you plan for it. 

If you treat just-in-time supply as a last-minute rescue, you may face supply interruptions, emergency sourcing costs, rush shipping fees, site delays, or missed dosing windows that could contribute to protocol deviations. In other words, your costs skyrocket quickly.  

The goal is to build a clinical trial supply strategy that is flexible, responsive, and ready to act when patient or site demand becomes clear.

This approach can reduce site burden, limit storage challenges, and help prioritize resupply to active and higher-enrolling sites. Rather than spreading inventory thinly across every location, sponsors can respond to actual enrollment patterns. 

Just-in-time supply can also work hand in hand with drop shipments.

Just-in-time planning helps determine when inventory should be released, while drop shipment can provide a way to deliver that product directly from an approved supply location to an approved depot, investigator site, hospital, or pharmacy, as permitted by the study and applicable regulations. This can reduce unnecessary handling steps and support a faster response, provided all requirements are carefully managed. Don’t forget that.  

Don’t forget this:Just-in-time supply requires smarter forecasting.

Sponsors still need visibility into enrollment expectations, site activation timelines, product lead times, shelf life, country requirements, storage conditions, and resupply triggers.  

The better the planning upfront, the more effective the just-in-time model.

For small and emerging biotechs, this matters. Every dollar and every timeline decision counts. Overbuying products, replacing expired inventory, or paying for unnecessary redistribution can pull budget away from other critical trial priorities. Just-in-time supply can help preserve capital while still supporting patient access, site readiness, and protocol execution. 

A just-in-time approach may not be appropriate for every product, market, or study. Several different variables may require inventory to be secured earlier. The best approach often combines appropriate safety stock with demand-based labeling, kitting, and distribution. 

Before using a just-in-time model, sponsors should identify which products are:

• Needed immediately 

• Needed only under certain protocol conditions 

• May have long lead times  

• Temperature-sensitive 

• Country-specific 

• Difficult to source 

• Likely to change based on protocol amendments 

The goal isn’t simply to hold less inventory. It’s to position the right inventory where it can be deployed most effectively. In Phase I and II trials, that can mean less waste, fewer delays, and more budget available to move your trial forward. 

Realizing you need a clinical supply planning and execution partner? We’d love to chat about where we can provide the most value to you and your clinical trial.  

Reach out at general@tannerpharma.com.