Clinical trial labeling is one of the most complex logistical challenges in the life sciences sector. With multi-lingual requirements, blinding protocols, and strict booklet label standards, there is zero margin for error. Discover how to manage global trial logistics while maintaining strict cGMP compliance and meeting tight patient recruitment deadlines.
Labels and Packaging – Critical for Clinical Trials
Labels are not simply words and images. They communicate critical information including dosages, patient instructions, ingredients, country-specific requirements, compliance and expiration dates. Every detail must be perfect.
Clinical trial primary and secondary packaging should be done right the first time to mitigate risk, improve the patient experience and streamline the supply chain:
- Primary packaging is vital to preserving the integrity of essential medication by preventing contamination with sterile barriers that meet regulatory standards. Primary packaging can also have informative content descriptions.
- Secondary packaging protects medication from physical damage during storage, transportation and distribution. It also protects from light, moisture and temperature fluctuations. Depending on the type of product and purpose, secondary packaging materials ensure the stability and integrity of these investigational products. This packaging can also help with traceability, such as randomization, blinding and even for tracking stock.1 Lastly, Instructions for Use (IFUs) often play an important role in human factors studies when evaluating a patient’s ability to operate new or updated medical devices.
The Right Partner to Optimize Your Clinical Trial Criteria and Effectiveness
Labels and packaging are an integral component of your clinical trial’s entire lifecycle — from design to distribution.
You may need a range of label types and services to execute your clinical trial, including:
- Clinical booklet labels
- Conventional clinical labels
- Clinical trial foldout labels
- Clinical trial wrap labels
- Single-panel and multi-panel labels
- Multi-lingual labels and translations
- Booklets and patient information inserts/outserts
- A variety of other custom-tailored labels
Paperwork, production schedules, regulatory pressures, traceability — you have enough to worry about with your work on healthcare-related products!
Consider outsourcing your labels and packaging needs to a reputable, efficient and experienced label solutions provider. This label partner should have proven processes and quick turn to ensure timely delivery of your clinical trial materials.
1. https://www.clinicaltrialsarena.com/sponsored/overcoming-regulatory-issues-with-investigational-medicinal-product-labelling/
