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easyTMF - electronic Trial Master File

Clinical Trial File Management & eTMF Submission

Product Purpose

Web-based platform leading all participants to systematically prepare and complete an  audit-proof GCP-compliant trial master file

  1. Assemble data into compliant template structure
  2. Collaborate virtually into one integrated result
  3. Automatic storage of full history
  4. Easy date- or object-related navigation

Value Proposition

Error-minimizing via intuitive template structure

Easy-to-use for all stakeholders

Effective risk management via integrated audit trail navigation and upfront compliance training

Time reduction for all participants in search, editing assembly of docs + quick-finding of historic events

ISF reconciliation option

Unique

Pricing starts at 1.5 K EUR per month per study
+ one time set-up fee including product training and compliance documentation

We want to make clinical trial management

a pleasant experience for all participating parties

No installation required

Reduced errors via intuitive templates

Easy-to-use for all stakeholders

Feb21028-2021 Biotechnology Awards Winners Logo

Quick-finding of historic events and data

Effective risk mgmt., audit-trail navigation

ISF reconciliation option

eTMF Navigation incl. “wayback”

Challenge

Integrating data and documents from various sources into an audit proof TMF and find events in audit

eTMF provides a virtual platform with easy-to-navigate file & history structures

Impact:

> Reduced time to achieve an audit-proof TMF
> Effective risk management
> pass audit

eTMF Progress

eTMF progress report & project management

Challenge:

Track progress to effectively manage project while virtually working on various data and doccuments

eTMF provides intuitive progress report and project management support functions

Impact:

On-time delivery and submission of eTMF

eTMF User Management

Challenge:

Different eTMF contributors have different levels of responsibility and experience

eTMF provides a systematic and well-controlled user management down to document level

Impact:

> Reduced risk to corrupt data and files
> reduced errors
> faster and safer submission