CRScube Inc.
cubeTMF - Streamlines the Workflow and Management of Documents
FromCRScube Inc.
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.
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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