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

LBR has completed multiple projects for Wyeth and specifically for the Women’s Health and Tissue Repair group. They have been outstanding in their commitment, quality, and attention to detail. They are there when you need them and do not prolong a project if unneeded. I can think of no better team when extra help is… Read more “Ginger Constantine, MD”

Ginger Constantine, MD

The expertise and knowledge LBR shared truly helped us accomplish our goals in IND preparation and Orphan Drug submission. We were very impressed by LBR’s speed, thoroughness, professionalism, and especially their dedication to our project—as if their team was an extension of our company.

Director

EnVivo Pharmaceuticals, Inc.

Let us help you run the best clinical program possible.

LBR, Inc | 1125 Boone Aire Road, Florence, KY 41042 | Phone: (859) 426-5035