At Luminer, our extensive experience and our technological capabilities enable us to provide a variety of clinical trial labeling options to meet essential criteria for maximum effectiveness and compliance for clinical trials and investigational studies.
Whether you’re seeking booklet labels and foldout labels to provide additional information or you need wrap labels as part of your clinical packaging and labeling checklist, we can provide the quality, consistency, and compliance required to support your important work in the pharmaceutical & healthcare sectors.
Uses & Applications
The important role of clinical trials has never been clearer than during the ongoing pandemic. But we also know that vaccine development for COVID-19 is just one way that clinical trials are used on a daily basis to protect and improve public health.
In order for investigational studies and clinical trials to move forward, specific labeling requirements must be followed. We understand just how critical maintaining accuracy is for your clinical labeling and how the demands of the pharmaceutical industry impact clinical trial labeling requirements.
These pressure-sensitive labels look just like miniature paper books or fold-out leaflets, as their name suggests. Clinical trial booklet labels are well-suited for studies that require extended content information to be included as part of the pharmaceutical product. These multi-layer labels can be applied automatically and can be printed in multiple colors.
Overall, this allows you to maximize content space while providing the extra information required in an efficient and aesthetically pleasing way.
With our clinical trial booklet labels, we can also add:
- Thermal imprintable overlams compatible with various ribbons
- Split base labels that allow the reseal to wrap around a 90-degree corner
- Imprintable peel-off labels for track-and-trace
- Specialized constructions for bottles, vials, syringes and cartons that mitigate lifting or wrinkling
Differing from booklet labels, clinical trial fold out labels allow for content to be printed on a large piece of paper before being holded and laminated to pressure-sensitive label stock. This single process happens all in-line and can be constructed to allow for removability or resealability.
Clinical trial fold out labels can also be manufactured for automatic or manual application. For clinical trial applications, fold out labels can be printed to include ingredients, directions, and regulatory information in multiple languages.
Designed specifically for small-diameter packages, wrap labels allow for additional content to be included while maintaining a simple appearance. These clinical trial wrap labels allow for an extended printable area for content that can be easily unwrapped and rewrapped without the need for additional closures (like rubber bands) or adhesive-related damage. Instead, the clinical trial wrap label will wrap securely onto itself and safely unwrapped to reveal the additional information as needed.
Typically used for cylindrical vessels and packaging, clinical trial wrap labels can be printed with fixed information or by the end-user through thermal transfer printing. With options for 100% opaque, partially clear, or fully transparent label stocks, you’ll have more control over the level of packaging visibility for your clinical trial or investigational study needs. These labels can also be manually or automatically applied.
Clinical Trial Labeling For Investigational Studies
The important role of clinical trials has never been clearer than during the ongoing pandemic. But we also know that vaccine development for COVID-19 is just one way that clinical trials are used on a daily basis to protect and improve public health.
In order for investigational studies and clinical trials to move forward, specific labeling requirements must be followed. We understand just how critical maintaining accuracy is for your clinical labeling and how the demands of the pharmaceutical industry impact clinical trial labeling requirements.
Clinical Trial Labeling Compliance
We know how vital it is that all clinical trial labeling requirements are followed to ensure accuracy and safety. All of the processes we use to create our clinical labeling products incorporate pharmaceutical Standard Operating Procedures (SOPs) every step of the way, from order placement and production to shipping and distribution.
Our operational practices and SOPs align with both FDA cGMP and ISO guidelines, providing you with the peace of mind you need. In the end, this means that your clinical trial labeling and packaging will follow all relevant production standards and will be free of errors that might otherwise be overlooked.
cGMP and ISO Standards
Our operational practices align with both FDA cGMP and ISO guidelines, providing you with the peace of mind you need.
Traceability and Documentation
We prioritize traceability and documentation throughout the entire label production process, making it easy to conduct audits as needed.
Annual Internal Audits
We conduct annual internal audits to ensure our Quality Management System adheres to ISO and other industry standards.
Thorough Inspection Systems
From spectrophotometers to machine vision and OCR/OCV readers, we ensure accuracy throughout the process.
Customized Clinical Trial Labeling Options
The realm of pharmaceutical labeling covers a wide range of needs. For clinical trials, a variety of labeling products may be used to provide both compliance and usability in mass quantities.
Whether you want to keep your clinical labeling as simple as possible or you require something a bit more robust, we can provide the flexibility, quality, and compliance you’re looking for.
We offer expanded content labels, booklet labels, foldout labels, wrap labels, and more that will meet both your clinical trial labeling requirements and your budgetary concerns. For more specialized functionality, we even offer customized labeling options.
With our variety of customizable products, use of cutting-edge technology, and experience in the pharmaceutical and biotechnology sectors, Luminer is uniquely positioned to provide you with the clinical labeling products to fit your study or trial.
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Customized Labeling Options
- Black-out/100% opaque label stocks
- Color matching less than or equal to 2 Delta-E
- Specialized adhesives for cryogenic and high temperature applications
- Thermal Transfer, Direct Thermal, Laser and Inkjet imprintable label materials
- Back-numbering for traceability and/or inventory control
- Lot number verification systems
- Double booklet detection system
- Bottle, vial and syringe compatible wraps and multi-panel labels
- Integrated tamper evident features via perforations, slits and/or frangible materials
- Customizable pattern adhesive coating
- Dust collection systems to mitigate paper dust
- Plastic cores to comply with dust-free environments
Ready to discuss your clinical trial label needs? Contact Us
