Sustainable Clinical Supply: Cutting Waste Without Cutting Corners

Clinical supply has a waste problem that everyone in the industry knows about and few talk about. It is common for a large share of the drug manufactured for a trial never to reach a patient. It expires on a shelf, gets stranded at a site that never enrolled, or comes back unused at closeout and goes to incineration. Add single-use cold chain shippers, express air freight, and sites that receive two shipments a week when one would do, and the environmental footprint adds up fast.

Sustainability used to be a nice-to-have in supply planning. Now big pharma sponsors have public emissions targets that include their trials, and some ask CROs and vendors to report carbon data. The good news is that most of what makes a supply chain greener also makes it cheaper.

Waste starts with overage

The biggest lever is the amount of drug you make and distribute. Overage protects patients from stockouts, but it is often set by habit, not analysis. A trial that runs at 300% overage when 150% would be safe is wasting active ingredient, packaging, manufacturing capacity, freight, and destruction costs all at once.

• Use simulation, not rules of thumb. Supply simulation shows the actual risk at different overage levels.
• Revisit settings during the study. Initial IRT buffers are based on guesses. Real enrollment data lets you trim them.
• Avoid seeding sites that may never enroll. Ship initial supply after the site is truly ready, not at activation.

Pooled and just-in-time labeling

Country-specific packaging locks stock into one country. When enrollment shifts, that stock cannot move and often expires. Multi-language booklet labels, pooled supply across countries, and just-in-time labeling at depots let one inventory serve many countries. That means less total stock and less of it expiring.

Reusable shippers

Single-use passive shippers made of expanded polystyrene and gel packs are still everywhere, and most of them end up in landfill. Reusable shippers, run as a rental or loop service, cut that waste and often perform better thermally. They do need a return loop, which works well for depot to depot and depot to large site lanes, and less well for remote sites or direct-to-patient shipments.

A practical approach is to use reusable shippers on high-volume lanes and keep single-use on low-volume or one-way lanes. Even partial adoption makes a visible difference.

Ship less often, ship by sea where you can

Air freight produces far more emissions per kilogram than ocean freight. Bulk drug product and long-shelf-life packaged kits can often move by temperature-controlled ocean container between regions, with air reserved for urgent resupply. This needs longer planning horizons, which is exactly what a good supply plan should provide anyway.

At the site level, review resupply frequency. Two small shipments a week to the same site cost more and emit more than one well-sized shipment. Tune IRT trigger and resupply quantities with that in mind.

Smaller kits, less air

Kit design affects freight volume. Oversized cartons, deep blister trays, and inserts for a few tablets mean you ship mostly empty space, and in cold chain that space needs cooling. Right-size packaging during kit design, and check how many kits fit in each shipper configuration.

Returns and destruction

Returned and expired product usually goes to high-temperature incineration. You cannot avoid that for most investigational products, but you can reduce how much reaches it by cutting overage and expiry. Some sponsors also redeploy unexpired, intact product from closed sites to active ones where regulations and quality agreements allow it. That needs strong temperature records and clear rules, but it can save meaningful amounts of drug.

Measure it

You cannot manage what you do not measure. Useful starting metrics:

• Percentage of manufactured drug actually dispensed to patients.
• Units destroyed due to expiry.
• Shipments per site per month, and average fill of each shipment.
• Share of freight by mode, and reusable versus single-use shippers.

These numbers usually make the business case on their own, because waste is cost.