Clinical trial label production requires a higher level of oversight and management than a commercial labeling operation to protect the integrity of blind, as well as meet stringent regulatory requirements and controls.
Our advanced inspection software, full in-house print capabilities, and proprietary translation and regulatory approval system are specifically designed to reduce overall label cycle times.
Case study highlight: Through our single-vendor approach for both clinical labeling and packaging, we helped an emerging biotech achieve significant cycle-time reduction to hit an aggressive FPI timeline. Download the case study to learn more.
Standard/Single Panel Manufacturing. |
5 Days |
Bulk Booklet Manufacturing | 10 Days |
Variable Print | 5 Days |
Clinical trial materials requiring ultra-cold storage demand labeling solutions that perform reliably under extreme conditions. Thermo Fisher Scientific's comprehensive in-house label capabilities offer a significant advantage, minimizing hand-offs, streamlining logistics, and enabling significant cycle time reduction.
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:
Specialized label materials and adhesives are designed to match application and storage temperature requirements, minimizing the risk of adhesion failure or readability issues.
Learn more about our comprehensive cold and ultra-cold supply chain management and logistics services.
Global network of clinical label production sites to support both local and global studies
Our facility in Bohemia, New York, provides leading clinical label design, production and management services for the pharmaceutical and biotechnology industry. Our Bohemia, New York site serves as the Center of Excellence for clinical label research and development including material and construction testing.
Comprehensive service line supporting all aspects of clinical trial supply—primary & secondary packaging, labeling; including both standard and booklet label production, regulatory support, distribution, returns and destruction. Flexibility to handle all types of clinical studies from Phase I to Investigator Initiated Studies (IIS), to the larger, more complex Phase II and Phase III studies.
This new facility is 30 minutes walking distance from our Special Economic Zone (SEZ) main facility (Free Trade Zone). This site offers high quality and cost competitive clinical packaging, labeling, comparator sourcing, ancillary management, storage and distribution services to support local clinical trials, i.e. local product local market.
Strategically located in a Free Trade Zone, clinical trial sponsors can realize significant cash flow advantages as there are zero duty and VAT payments imposed on shipments entering Suzhou. Kits can be packaged and labeled in Suzhou bonded zone to support APAC studies while sponsors in China wait for the clinical trial approval document. Capabilities include clinical packaging, labeling, ancillary management, storage and distribution services to support local clinical trials.
Our multi-lingual team has proficiency in English and a true appreciation of cultural nuances.