Need help with Veeva Vault eTMF?

Bring Phlexglobal expertise to Vault or any other eTMF tool.

shutterstock_2016196394

Expert Support for Veeva Vault eTMF

 

Phlexglobal has led over 25 projects related to Veeva Vault eTMF over the past year.

 

Contact Us

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:

Integrated-01

Multiple migration and remap projects from CRO, legacy eTMF to Vault eTMF

Artboard 1-2

Inspection Readiness consulting, mock inspection, ongoing support

TMF Tools-01

TMF Quality Review & Heatmap metrics for completeness, timeliness, etc

Active Management-01

Developed Vault eTMF specific SOPs, Training Guides, consulting workshops and advisory services

Support-01

TMF Operations Support (and Helpdesk), TMF Study Owners resourcing

TMF Process Optimization-01

Veeva system implementation and deployment consulting services

Veeva Vault Case Study

Balancing People, Process, and Technology - In 2016, quite late into their Veeva implementation, a Top 25 global pharmaceutical company was in need of TMF expertise to overcome both strategic and tactical business problems. Phlexglobal had solutions for both.

Integrated-01Tactical 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.

TMF Technology-01Phlexglobal Solution: Every document was successfully  migrated to acceptable quality levels within the agreed  upon 9-month time frame and under budget.

 

TMF Tools-01Strategic 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.

Processing-01Phlexglobal Solution: Phlexglobal now reviews 30,000  a documents a month to agreed quality levels with a  document turnaround that typically sits at 2 days.

Infographic Computer Screen Veeva Services

Phlexglobal Experts Fill the Gaps in eTMF
Management, in Your eTMF System

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

  • On-call, highly scalable global expertise to manage document processing backlogs and unexpected demand
  • Dedicated TMF experts to focus 100% on TMF management and inspection-readiness, freeing up your study teams
  • Expert Quality Review and Quality Control embedded in workflows to ensure ongoing inspection-readiness
Digital Brain Header Large Brain Right

It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
Contact Us

Latest News

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or

Key Trends and Hot Topics from the Fierce TMF Summit US

Introduction: Trial Master File (TMF) experts are acutely aware of the growing complexity involved in meeting compliance obligations and improving overall quality and completeness. As those working

Staying on Top of the Trial Master File

As regulatory agencies increasingly focus on the processes and workflows behind the Trial Master File (TMF), not just on what it contains, the pressure has increased on sponsors to ensure theirs is