Eliminating Experimental Drug Waste Through Responsive JIT Supply Chains

Traditional clinical trial supply vendors force sponsors into rigid, large-scale production runs. These remote suppliers treat critical, temperature-sensitive experimental therapies like standard commercial cargo, exposing trial sponsors to massive product loss whenever a mid-study amendment occurs.

• Excessive API Waste: Traditional vendors mandate bulk runs early. When protocols shift, thousands of pre-packaged units must be destroyed. Patwell packages specifically for enrolled patients, saving valuable compound.
• Protocol Flexibility: Mid-study changes derail standard providers. Patwell adapts to expiration extensions, dosing adjustments, and design updates.
• Direct Auditability: Remote vendors operate behind black-box call centers. Patwell encourages sponsors to visit our facility in Chester County, inspect security, audit temperature controls, and speak face-to-face with logistics experts.

Preserving the stability of experimental therapies requires uncompromised environmental control. Operating out of a 20,000-square-foot footprint in Coatesville, Patwell offers secure storage configurations engineered to accommodate every phase of clinical trial development.

Controlled Storage Capacities

• Controlled Room Temperature (CRT 20°C to 25°C): 92,400 cubic feet of dedicated space offering 2,000 pallet and shelving locations.
• Walk-In Refrigerated Storage (2°C to 8°C): 4,400 cubic feet housing 648 shelf locations.
• Walk-In Freezer Storage (-10°C to -25°C): 800 cubic feet housing 500 shelf locations.
• Ultra-Low Temperature Storage (-65°C to -85°C / -80°C Target): 26 cubic feet of ultra-low freezer capacity.

Our facility uses 24-hour continuous environmental monitoring backed by full emergency backup generator power to protect valuable clinical inventory around the clock. Onsite packaging assets include five secondary packaging rooms along with one limited primary packaging room equipped with a specialized hood.

Patwell modifies its full suite of packaging and labeling services to align with study protocols ranging from straightforward Phase I trials to complex, multi-site Phase III international studies.

• Custom Labeling Solutions: Comprehensive capabilities covering de-labeling, over-labeling, sachet and pouch labeling, expiration date extensions, and on-demand variable print runs.
• Cold Chain Kit Assembly: Precision assembly of secondary packaging and ancillary kits inside temperature-controlled zones for refrigerated or frozen therapeutics.
• Child-Resistant Packaging: Protocol-compliant packaging configurations designed to safeguard clinical trial subjects.
• 100% Accountability & Reconciliation: Federal regulations mandate total drug accountability. Our team manages site closeouts, performs full reconciliation down to tablet-level counts, handles kit disassembly, and provides documentation prior to certified destruction at licensed facilities.