Clinical supply runs on kit identity: every carton has to be traceable to a kit type, a treatment code and a batch, and the pack has to show whether it has been opened. A clinical trial kit carton on reverse tuck end construction carries a dedicated variable data area on a flat panel, clear of folds and scores, plus a tamper-evident seal across the tuck flap that breaks visibly on first opening.
The carton runs on Solid Bleached Sulfate 16 pt, roughly 300 gsm, which keeps the pack light for shipment and stiff enough for a tuck flap to hold a seal. Codes are customer-supplied: kit numbers and treatment codes are printed into the variable data area exactly as delivered and verified against the supplied code file before release.
Base graphics print offset or digitally, and the variable data area is overprinted, so a code revision does not need a new base plate. Each kit type runs as a separate job, and finished bundles are labelled by kit type and held apart before packing.
- Codes survive handling, because the variable data area sits on a flat panel away from folds, scores and the tuck flap.
- Opening history is visible on the pack itself, because the tamper-evident seal breaks across the tuck flap on first opening.
- Print version control and change notification: every artwork revision is version-locked and released against a signed proof, so a superseded print cannot reach your line.
- Batch traceability with retained samples: each lot is recorded against its board reel and print run, and a retained sample is held so any question can be resolved against the actual production piece.
- Written quality agreement and open audit: we sign the quality agreement and open the production floor to your audit team, including artwork, printing and packing areas.
- Blinded investigational and comparator kit cartons for clinical supply
- Patient kit cartons for visit-based dispensing
- Ancillary item kits for diaries, swabs and tubes
- Rescue medication kit cartons
- Open-label supply cartons for extension phases
Who supplies the kit and treatment codes?
Codes are customer-supplied. They are printed into the variable data area exactly as delivered and verified against your code file before release; treatment allocation is not generated at the printing stage.
How are blinded kit types kept apart during production?
Each kit type runs as a separate job with its own plate or data file. Finished bundles are labelled by kit type and held apart before packing, so two kit types are never on the same bench at the same time.
What makes the seal tamper-evident?
A tamper-evident seal is applied across the tuck flap, so the first opening leaves a visible break on the flap and on the seal. Seal placement is checked on the first article before the run continues.
Does the carton suit small patient-number batches?
Digital printing keeps short kit quantities runnable, and the variable data area is the same on every batch. Minimum order quantity is quoted per kit type rather than across the study.
How do you prevent a superseded artwork version from being printed on our next run?
Artwork is version-locked at release. Every revision is registered against a version number and released against a signed proof, and the superseded plate or data file is withdrawn from the press area, so the file on our system and the file on your line carry the same version. A written change notification is issued before the next run starts.
What happens if a defect is found after our lot has shipped?
Your lot number resolves to the board reel and print run that produced it, and a retained sample from that lot is held on file. We pull the retained sample and the inspection record for the batch, compare them against the signed proof, and report what the production piece actually looked like.
