As a full-service provider for document intake (paper and electronic), indexing, upload and QC into Vault eTMF, ongoing QC, and archival of hundreds of studies, Phlexglobal has provided the following services to Vault eTMF customers:
Multiple migration and remap projects from CRO, legacy eTMF to Vault eTMF
Inspection Readiness consulting, mock inspection, ongoing support
TMF Quality Review & Heatmap metrics for completeness, timeliness, etc
Developed Vault eTMF specific SOPs, Training Guides, consulting workshops and advisory services
TMF Operations Support (and Helpdesk), TMF Study Owners resourcing
Veeva system implementation and deployment consulting services
Tactical Problem: Document Migration
As part of their Veeva implementation, The Client migrated all TMF content from their previous FirstDoc to Veeva Vault. While millions of documents were successfully migrated, 275,000 documents needed a TMF expert to decide on the correct filing location.
Phlexglobal Solution: Every document was successfully migrated to acceptable quality levels within the agreed upon 9-month time frame and under budget.
Strategic Problem: Low Performance
The Client was experiencing performance issues with its existing TMF services provider which held to a 6-week document processing SLA and low quality levels. They Client sought a partner with TMF expertise that could perform real-time quality control checks within their system.
Phlexglobal Solution: Phlexglobal now reviews 30,000 a documents a month to agreed quality levels with a document turnaround that typically sits at 2 days.

Download the infographic to discover why companies rely on Phlexglobal's unmatched expertise to manage shifting demand
and improve inspection-readiness.
PHLEXGLOBAL WORKS IN
YOUR OWN eTMF SYSTEM TO
SOLVE THE CHALLENGES YOU
FACE EVERY DAY
When my Trial Master File (TMF) career began, the TMF Reference Model did not exist. Every customer had a different way of organising the contents of their TMF, and it was rarely interpreted
Building the Right TMF Team for Inspection Readiness, Scalability and Growth As clinical trials become more complex, many Sponsors and CROs find themselves asking the same question: Do we need more
Why portfolio-level TMF oversight is becoming a necessity, not a luxury. The Problem With Thinking Study-by-Study Clinical trials do not happen in isolation. Sponsors and CROs are running multiple
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