The protocol is airtight.The packaging should be too.
Clinical supply runs on precision, every IMP shipment is documented, every temperature event is a potential deviation, and the study timeline doesn’t move for cold chain failures. TempAid gives you a validated system built for the audit trail your study requires.
In a trial, a temperature event isn’t a logistics problem. It’s protocol.
An IMP excursion is a deviation, not a reshipment
Every temperature event generates a deviation report, a QP review, and a potential patient safety inquiry. The cold chain isn't logistics, it's protocol.
Multi-country distribution, one validation package
EU, North America, APAC, different ambient profiles, different health authority requirements. The validation needs to cover every geography your sites are in.
Patient kit disposal at site and home
Sites and patients are left with cold chain packaging they didn't order. Recyclable patient kits reduce protocol waste burden and site complaints.
Validated for the study you’re running. and the audit that follows it.
Summer and winter profiles, both covered
Your sites span geographies with different seasonal ambient profiles. Both are validated. One system, all seasons.
Frozen lane for advanced therapies
Cell therapy, gene therapy, and advanced biologics require frozen distribution. Cube handles it with the same documentation standard as your refrigerated lanes.
EarthWise for patient-facing kits
Patient kit packaging that goes to homes and sites for disposal, curbside recyclable, reducing site waste burden and removing a common patient complaint from your protocol.
Custom qualification for novel molecules
If your stability profile doesn't fit ISTA standard targets, the Innovation Lab runs the custom thermal qualification, aligned to your stability data, delivered with a report your QP can use.
The shipper your supply team and your QP both sign off on.
SteadyPac Solo
VIP thermal performance in a single-use corrugated shipper, built for one-way lanes where reverse logistics isn't practical.
Details
SteadyPac Move
Reusable insulated transport for last-mile and field runs. Cube-grade VIP performance in a rugged carry bag.
Details
SteadyPac Cube
Vacuum panels that survive ISTA 3A drop tests across all corners and edges. Maintain performance during the full five-year lifespan.
Details
SteadyPac EPS
The proven EPS format with a better end of life, biodegradable additive validated to 92% biodegradation (ASTM D5511).
Details
SteadyPac EarthWise
Cold chain performance, blue bin at the end. OCC-E certified curbside-recyclable, ISTA validated to 130+ hours.
Details
SpeedyPac PCM Mailers
Curbside-recyclable mailers with the same PCM plate family, right-sized for single-parcel, last-mile temperature control.
Details
No two shipments are alike.We design for that.
If your shipment needs something the standard product line doesn’t carry, we’ll build it with you. We start by learning your lane, your warehouse conditions, your payload, and your temperature window.
Our in-house lab runs the testing, and we design the pack out around what we find. You get the test data, the qualification documentation, and a pack out built for your specific shipment. You’ll know before you commit.
Your monitor asks about the cold chain. Your coordinator pulls a binder. It’s all there.
Study-ready materials, formatted for your IMP dossier and your CTA/IND file.
Qualification summary
Study-ready, formatted for your IMP dossier or CTA/IND file.
ISTA test reports (7D / 7E)
Summer and winter ambient profiles, signed and dated.
Pack-out SOP
Structured for protocol inclusion and site training.
Deviation log template
Formatted for clinical trial deviation reporting.
Recyclability certificate
OCC-E documentation for patient kit configurations.
Custom Lab report
Full thermal qualification report on TempAid letterhead.
Build a documentation package ready for your regulatory file.
Tell us your IMP, temperature range, and site geographies. We’ll specify the right configuration and deliver a package ready for your CTA/IND file.
Get in touch