Electronic Trial Masterfile

The LBR Team is experienced in the development and maintenance of eTMF for the clinical trial. LBR uses Veeva Vault software to manage documents real-time. The eTMF is generated to ensure a constant state of inspection readiness, increase visibility, and maintain oversight to improve collaboration. The eTMF is accurately and quickly transferred to Sponsors.

eTMF Services Include:

  • Trial Master Files
  • Orphan Drug Application Preparation and Submission
  • eCTD Preparation & Conversion for all types of documents
  • Package Insert Development
  • Label Development & Review
  • Advertisement Copy Review