In November 2018, PPD implemented a new label text development solution, a critical step within the clinical trial startup process. Tasks associated with label text development include country submissions, printing of materials and packaging and/or labelling. Any delay on these activities directly impacts the time when drugs become available.
We have extensive experience developing label texts with robust phrase and translation memory in place that fulfills requirements in numerous countries. All steps in our process are connected in one system portal that provides full visibility and traceability. This also allows for standardization, which generates text more quickly and accurately and ensures compliance and flexibility.
Advantages of LRA:
- Accelerates label approval process
- Approved and standardized phrase and translation library
- Pre-determined routing groups and approval process
- Ability to build reusable templates to increase efficiencies
- Eliminates existing paper processes
- Integration with label design and printing; streamlined label design approach from text development to text printing
- Smart management of variable text on phrases not affecting or extending timeliness
- Provides complete visibility of approval routing process
- 21 CFR Part 11 compliant audit trail and approval/rejection history
- Reduced timelines for label creation by 45 percent, supporting shorter startup timelines