Clinical Label Services
Label design and translation management to reduce cycle times
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.
Clinical trial label services highlights
- ATLASSM translations management system
- Guidance on study label setup and randomization
- Full design capabilities (you only need to provide English text)
- Label design and manufacture integrated with regulatory, packaging, and clinical logistics
- Individual batch record control and release on a job-by-job basis
- Single and multi-panel labels, multilingual booklet labels
Standard/Single Panel Manufacturing. |
5 Days |
| Bulk Booklet Manufacturing | 10 Days |
| Variable Print | 5 Days |
Clinical trial label regulatory requirements
- Clinical trial label content requires stringent quality and regulatory review. Expansive translation management services facilitate streamlined regulatory review and compliance with up-to-date regulations.
- Whether utilizing ATLAS system for the ability of building a phrase library or for regulatory review per clinical label program our expert services will ensure review for all appropriate regulatory requirements, meeting all Country and region specific clinical trial regulations.
Booklet Label Services
- With up to 60 pages available for more than 100 languages, you have more room to add critical text, larger patient friendly text size, and color
- Booklet labels are fully laminated including variable print and include 100% camera inspection of inner pages
ATLASSM (Alternative Translation & Label Approval System)
- Cloud based, Clinical label-specific, validated translation and approval management system for online label order, text translation, and approval through label manufacturing
- Can reduce clinical label manufacturing timelines by more than 50%
- Ability to store and auto-populate standard phrase library and country specific regulatory requirements to streamline repeat orders.
- Monitoring and management of translation tasks to foreign affiliates for approval
- Non-compliant user escalation process and detailed performance metrics tracking
Our Clinical Labeling Sites
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.
Helpful Resources