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.

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


Industry Best Timelines*

Standard/Single Panel Manufacturing.

5 Days
Bulk Booklet Manufacturing 10 Days
Variable Print 5 Days
 *Timeline from proof and variable data approval

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 

Helpful Resources