cubeTMF

In the coming paperless era, the clinical trial environment is also changing. So far, the Trial Master File (TMF) has consisted primarily of paper documents, captured images, or media in physical file cabinets, but in order to provide a more economical and expeditious clinical trial process, In accordance with FDA's CFR 21 Part 11, we have developed this eTMF solution to achieve the ultimate paperlessness in clinical trials.

cubeTMF will help you comply with government regulations and electronically manage documents, images and other digital content for clinical trials electronically.

Store Trial Master Files on cloud server

By avoiding the constraints of physical space, more efficient conservation can be achieved (free from risks such as fire)
Prevention of violations through integrated document management and quality assurance through electronic records management
→ Adherence to clinical trial compliance and completeness & accuracy

Advantages of Document Management

  • Write

Quick and accurate documentation Logical and structured document classification

  • Review

Documentation progress monitoring
Document review and comment
Risk management and reporting

  • Approval

Simplify document submission and approval
Facilitate investigation and audit response

  • Store

Based on TMF Reference Model

Real-time document tracking and management

  • Quickly check the status and change history of all clinical trial documents
  • Real-time management of documentation progress
  • Centralized management of missing and due-date-passed documents
  • Identify potential risks ahead of time

KEY FEATURES & BENEFITS

Main page provides various information at a glance

  • Provide graphical indicators of the status of documentation / review procedures for each task.

Convenient Template Management

  • Provided the basic format of TMF Reference Model.
  • Various Customization Functions by Template / Category / Document.

Configure individual workflows by vendor / document

  • Detailed configuration functions for document review procedures.
  • Convenient confirmation of the progress of each document.
  • Thorough security policy by workflow level.

Document Handling

  • Provides convenience in document management procedures such as automatic PDF conversion of documents and simple version control procedures.
  • Provides detailed Bird-Eye-View for each document / document category.
  • Convenient document management functions such as individual / batch upload of documents.
  • Various Alarm Notice.
  • Convenient and versatile tools for reviewer.

Qualification

  • Detailed history management through Audit Trail.
  • DIA's eTMF Reference Model 3.0 based system

The convenience of cloud services

  • Easy access to entire document via login, regardless of where you are.
  • Provides reliable document preparation and convenient documentation in external / internal audit.

AT-A-GLANCE

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