From IIT studies with one or two sites to dynamic randomization/distribution strategies managed by IVRS systems; from unilingual, country-specific packaging to global supplies strategies employing multi-lingual, expanded content booklet labels; and the growth of the biopharmaceutical industry and its broadening range of controlled-temperature supply chain solutions — we’ve experienced it all.
Clinical Label Management
The labeling and packaging of your drug is an intricate and vital piece of your project. While industry requirements continue to change, our team keeps up-to-date and understands how these changes affect your packaging needs. We’ve likely tackled much of with what you’re dealing with, including:
- Distribution to study sites of small blocks of material
- Dynamic randomization/distribution managed by IVRS systems
- Unilingual, country-specific packaging
- Global supplies strategies employing multilingual expanded content booklet labels
- The rise of the biopharmaceutical industry, with its emphasis on parenteral drug administration and controlled-temperature supply chains
— Just to name a few!
Expertise ensures success
Regardless of the study phase, the magnitude of the trial, dosage forms being studied or trial design, we have the experience to ensure the successful execution of your clinical packaging project. Our team will evaluate solutions for your primary and secondary packaging needs.
Our primary packaging capabilities include:
Our secondary packaging capabilities include:
- Kit assembly
- Ancillary supply kits
- Expiry extension labeling
Precise and accurate labeling
Ensuring regulatory compliance, providing succinct instructions to study patients and sourcing materials that can withstand cold temperatures are just a few of the labeling challenges we know you face. We understand how crucial it is to find the right customized solutions that will contribute to the success of your trial.
Through our in-house ClinPro® fully validated clinical labeling system, we support all trial designs and the printing of:
- Open labels
- Blind or double-blind labels
- Randomized labels
- Single and multi-panel clinical labels
- Multi-language clinical labels
We also provide booklet labels incorporating multiple languages. Your dedicated project manager will facility translations, regulatory approvals and proofing throughout the project.