PhlexTMF Express

Pre-configured Trial Master File management with AI-assisted indexing, digital document processing, and inspection-ready workflows—live in 7-10 days.

Overview

PhlexTMF Express is a pre-configured electronic Trial Master File (eTMF) software solution developed by Phlexglobal, designed for life sciences companies that want to improve inspection-readiness and operational productivity without requiring customisation. Built on Phlexglobal's established TMF best practices, the software is delivered with a "gold standard" eTMF configuration out of the box, allowing organisations to go live in as little as 7–10 days. It is suited to companies seeking a purpose-built eTMF system that follows TMF Reference Model structure from day one.

PhlexTMF Express is offered on a per-study pricing model, providing flexibility for organisations managing individual or smaller numbers of studies. Companies with more complex requirements — such as multiple TMF structures or unique document processing needs — are directed toward PhlexTMF Enterprise.

Core Features and Capabilities

Pre-configured eTMF software built on Phlexglobal's gold standard best practices, processes, and services
TMF Reference Model structure included out of the box
AI-assisted indexing for document classification
Digital document processing for active studies
Quality Control (QC) functionality
Query set-up and management
Completeness reporting
Audit and inspection support
Read-only viewing access for closed studies
Automatic software upgrades

User Tools and Access

PhlexTMF mobile scanning and document classification app, available on iOS and Android
User management and study set-up capabilities
eLearning training resources for end users
Global support available across multiple regions

Deployment and Onboarding

Customers are typically up and running within 7–10 days due to the pre-configured nature of the software
No customisation required, as the system is built to TMF best practices from the outset
Per-study pricing model offers flexibility for organisations with varying study volumes

PhlexTMF Express is a cloud-based eTMF solution with global support coverage, including offices in the US, UK, Poland, and Germany. It is validated software intended to support regulatory inspection-readiness throughout the clinical trial lifecycle.