Clinical Trial Labels
Clinical trial labels are specialised labels used in the packaging of investigational medicinal products (IMP), demanding the highest levels of accuracy and traceability. Depending on the study protocol they include blinding, a randomisation number and a detachable subject-record section.
The margin for error in this product group is effectively zero. Variable data printing, 100% camera inspection and lot-based archiving verify that every single label was printed with the correct content; the production process is run with GMP and the relevant regulatory requirements in view.
Key features
- BlindingOpaque layers and masking print conceal the identity of the product.
- Detachable sectionsPerforated parts are applied to the subject file or case report form.
- Variable dataRandomisation number, kit number, expiry date and barcode are printed individually.
- Multilingual contentAll country languages of a multi-centre study are collected in one booklet.
Where is it used?
Clinical Trial Labels applications are most often implemented in the following areas:
- Clinical trial kits (IMP)
- Ampoules, vials and syringes
- Blister and cartridge packs
- Specimen and biobank tubes
- Medical device packaging
- Hospital and pharmacy applications
Technical specifications
| Quality control | 100% camera verification, double reading, lot-based archive |
|---|---|
| Traceability | Batch/lot number, GS1 barcode, DataMatrix, QR code |
| Constructions | Blinded, detachable, booklet, multi-layer |
| Material | Cryogenic, refrigerated and room temperature adhesive options |
| Documentation | Print approval form, sample archive, production record |
Let us start with a sample. Before series production we print a digital sample and recommend testing it on your own filling line where possible. Folding structure, legibility and adhesive performance are then verified before production starts.