cubeTMF

 

Model: eClinical Solutions

Category: *CRO

Exhibitor: CRSCUBE INC.

Booth No: L629

 

Characteristic

 

In the paperless era, the clinical trial industry is changing. Until now, the Trial Master File (TMF) has consisted of traditional paper documents, images, or media organized in a binder stored in file cabinets. In accordance with FDA's CFR 21 Part 11, we have developed cubeTMF to provide a validated system for a cohesive workflow for a truly paperless clinical trial. cubeTMF® streamlines the workflow and management of documents, images, and other digital content for clinical trials.

BENEFITS
Web-based system
Free basic training (In-person or web-based)
Compatible with DIA TMF reference model
Regulatory compliance
Audit trail
Electronic signature workflows
QC workflow
Manage and document tracking in real-time
Notifications & alerts for missing and overdue documents
Graphical indicators of the status of documentation/review procedures for each task
User dashboard

Template Management
Customizable eTMF binder structure
Simple and intuitive document uploads with document templates

Customizable workflow
Detailed configuration functions for document review
Convenient progress confirmation for each document
Thorough security protocols for each workflow level

Document Management
Individual/batch upload
Convenient review process and intuitive tools

Compliance
Detailed history management with Audit Trails

Cloud services
Easy access to entire TMF
Document preparation and convenient document storage for external/internal audit

 

Other Products

 

• 

  cubePRO

• 

  cubeIWRS

• 

  Centralized Monitoring VIA

• 

  cubeSAFETY

• 

  cubeCDMS(EDC)

• 

  cubeCTMS

• 

  cubeCONSENT

• 

  cubeDDC

 

 

 

Back