Clinical trial label services
Delivering compliant, multilingual clinical trial labeling services with speed and accuracy, aligned with current global regulatory requirements.
Label design and translation management to reduce cycle times
Clinical trial label production for investigational medicinal products requires a higher level of oversight and management than commercial labeling operations to protect the integrity of blinded research studies and to meet stringent regulatory requirements and controls across regions.
Our advanced clinical labeling services, including inspection software, full in-house printing capabilities, and a proprietary translation and regulatory approval system, are specifically designed to reduce overall label cycle times—helping to speed up your trial timelines.
Case study highlight: Through our single-vendor approach to both clinical labeling and packaging, we helped an emerging biotechnology company significantly reduce cycle times and meet an aggressive FPI timeline.
Why choose our clinical trial label services?
Thermo Fisher’s clinical trial label services are designed to reduce complexity, accelerate timelines, and ensure compliance across global studies.
Key highlights of our capabilities include:
- Proprietary ATLAS translation management system
- Expert guidance on study label setup and randomization
- End-to-end design capabilities—only English source text required
- Design and manufacturing aligned with regulatory, packaging, and clinical logistics
- Individual batch record control and job-by-job release
- Single- and multi-panel labels, including multilingual booklets
Industry-leading turnaround times*
5 days
10 days
5 days
*Timelines begin upon approval of proofs and variable data.
Through our single-vendor approach to both clinical labeling and packaging, we helped an emerging biotech company significantly reduce cycle times and meet an aggressive FPI timeline.
What our clinical trial labeling services include
We provide end-to-end clinical trial labeling services designed to support complex global studies and meet evolving regulatory requirements.
Booklet label services
- With up to 60 pages available in more than 100 languages, you have more room to add critical text, use larger, patient-friendly font sizes, and incorporate color
- Booklet labels are fully laminated, including variable print, and include 100% camera inspection of all inner pages
ATLASSM (Alternative Translation and Label Approval System)
- Cloud-based, clinical label–specific, validated translation and approval management system for online label ordering, text translation, and approval throughout the label manufacturing process
- Can help reduce clinical label manufacturing timelines by more than 50%
- Ability to store and auto-populate a standard phrase library and country-specific regulatory requirements, streamlining repeat orders
- Monitoring and management of translation tasks with foreign affiliates for approval
- Non-compliant user escalation processes and detailed performance metric tracking
Regulatory support for clinical trial labeling
- Clinical trial label content requires rigorous quality and regulatory review; comprehensive translation management services facilitate streamlined regulatory review and compliance with up-to-date regulations across regions
- Whether utilizing ATLAS to build a phrase library or to support regulatory review for each clinical label program, our experts ensure all applicable requirements are met, including country- and region-specific clinical trial regulations
Ultra-low temperature labeling
Clinical trial materials requiring ultra-cold storage demand labeling solutions that perform reliably under extreme conditions. Thermo Fisher’s end-to-end, in-house labeling capabilities offer a significant advantage, minimizing hand-offs, streamlining logistics, and reducing overall cycle times.
Our ultra-low temperature label services provide standard, custom, and patient-specific labeling—all applied at temperature to ensure label integrity and compliance from production through storage and distribution. Our solutions are engineered for use across a full range of ultra-cold conditions:
- 2°C to -8°C
- Frozen conditions
- Cryogenic environments
Specialized label materials and adhesives are designed to match application and storage temperature requirements, reducing the risk of adhesion failure and ensuring readability.
Read our case study: Internal validation study: Ultra-low temperature labels
Learn more about our comprehensive cold and ultra-cold supply chain management and logistics services.
ePLY: Digital content delivery for modern clinical trials
ePLY is our new digital content distribution platform designed to enhance the clinical trial experience by making essential drug information more accessible to patients. Instantly available by scanning a QR code on the clinical label, ePLY provides a customized website where patients can easily view supplemental materials—such as dosing instructions, medication prep videos, infographics, and digital leaflets—in their preferred language.
Fully customizable for biotech and biopharma sponsors of all sizes, ePLY is built to support any clinical trial model, including site-based or direct-to-patient. It’s flexible enough to accommodate program-specific content and allows for late-stage updates, including manufacturer address changes or expiry date modifications. By streamlining how patients receive and understand clinical trial information, ePLY helps improve safety and adherence.
Watch our video to see how ePLY works.
To explore ePLY in depth, read our fact sheet.
Integrated clinical trial packaging and labeling services
Our clinical trial label services were developed to integrate seamlessly with our clinical trial packaging capabilities, helping streamline operations, reduce handoffs, and speed up study timelines.
By combining labeling and packaging within a single network, we help reduce complexity across clinical supply chains while maintaining compliance and quality from label design through final kit assembly.
Frequently asked questions (FAQs) on clinical trial label services
We provide single-panel and booklet labels up to 60 pages in length, available in multiple formats to meet a wide range of clinical packaging specifications and configurations.
Yes. Our comprehensive translation management services support streamlined regulatory review and ensure compliance with current global regulations.
Absolutely. Our booklet labels can accommodate more than 100 languages and up to 60 pages, providing room for critical text while meeting international regulatory requirements.
We ensure accuracy through fully in-house printing capabilities, a proprietary translation and regulatory approval system, and integrated advanced inspection software. These quality controls include 100% camera inspection of inner pages for all digital booklet labels.
ePLY™, our digital content distribution platform, enables patients to access information by scanning a QR code on the label. This solution can be used across any clinical program and delivers information in a streamlined, easy-to-view format.
Our clinical trial labeling sites
Our global network of clinical label production sites can support both local and global research studies of any size, at any phase.
Our facility in Bohemia, New York, provides leading US-based clinical label design, production, and management services for the pharmaceutical and biotechnology industries. This site is recognized as a center of excellence for clinical label research and development, including material and construction testing.
Our Basel facility offers a comprehensive suite of services supporting all aspects of clinical supply, including primary and secondary packaging, labeling for both standard and booklet formats, regulatory support, distribution, returns, and destruction services. The site has the flexibility to support all types of clinical studies, from Phase I and Investigator Initiated Studies (IIS) to larger, more complex Phase II and Phase III trials.
This new facility is located within walking distance of our main Special Economic Zone (SEZ) facility in the Free Trade Zone (FTZ). The site offers high-quality, cost-competitive clinical packaging, labeling, comparator sourcing, ancillary management, as well as storage and distribution services to support local clinical trials, helping provide local products to local markets.
Strategically located in a Free Trade Zone (FTZ), this site enables sponsors to realize significant cash flow advantages, with zero duty and VAT payments imposed on shipments entering Suzhou. Kits can be packaged and labeled within the Suzhou bonded zone to support APAC studies while sponsors in China await clinical trial approval documents. Capabilities include clinical packaging, ancillary management, and storage and distribution services. Our multilingual team is proficient in English and understands regional cultural nuances.
Helpful resources for clinical trial labels