Alternative Translation & Label Approval System (ATLAS)
The Alternative Translation & Label Approval System (referred to as ATLAS) is Clintrak’s proprietary web based tool used for translation management. The industry’s first clinical, web-based, label-specific translation and approval management system, ATLAS, that comprehensively addresses the full spectrum of label development,streamlining the process from text translation and approval through label manufacturing.
This system combined with our extensive project management expertise provides:
- Flexibility and ease of use to translate text with a single mouse click
- Ability to store and auto-populate country specific regulatory requirements
- Monitoring and management of task translations to foreign affiliates for approval
- Non-compliant user escalation process
- Detailed performance metrics tracking
Currently being utilized by pharmaceutical and biotech companies globally, ATLAS has demonstrated a reduction in clinical label manufacturing timelines by over 50%.
Typically, clinical label production is on the critical path to bringing an investigative drug to market. The length of time it takes to generate and receive approval of label text for dozens of countries participating in a clinical trial however, can be time consuming and ultimately lead to costly bottlenecks.
ATLAS offers several approaches for handling phrase libraries as well as providing easy to use on-line ordering capabilities to further streamline clinical supply chain timelines. The web-based tool is complemented by experienced Clintrak project managers that support ATLAS clients throughout process development, and training.
ATLAS addresses the needs of our clients by focusing on their three main concerns: Cost, Cycle Time Reduction and Quality. By building a standard phrase library with country specific regulatory information, there is no need to constantly pay for the same work to be done over and over again. With access to a standard or customized phrase library, our team can generate your label text instantly, based on your web order and using a validated system that ensures that label text will populate correctly every time.
Customers who are interested in viewing a demo of the system or learning about how we have been able to integrate it into an ongoing operation, contact us here.