Full document management combined with clinical trial logic
Clinical Data Management
- Maintains visibility, status and control of trial documentation
- Enables faster and more efficient site setup and initiation
- Streamlines key business processes through integrated workflows
- Ensures file structure and organization quality with support for the DIA TMF Reference Model
Centralized Electronic Trial Master File Solution
LifeSphere eTMF is a centralized, global electronic trial master file solution for managing, accessing and archiving all trial-related documents. A fully validated, 21 CFR Part 11-compliant electronic TMF solution, LifeSphere eTMF enables complete sponsor and investigator site files to be rapidly created for each study, and helps to ensure readiness for audits and inspections.
Full document management is combined with clinical trial logic to support the lifecycle of each document and aid the trial management process. Authors can upload new documents and start a workflow-driven review-and-approval process.
A multi-tenancy cloud-based TMF solution, LifeSphere eTMF quickly uses powerful search criteria to enable rapid access to documents in the system, regardless of the status. LifeSphere eTMF integrates out of the box with LifeSphere® CTMS and LifeSphere® Investigator, helping clinical operations teams reduce data-entry efforts and ensure consistency of data.