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 serverBy 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
Quick and accurate documentation Logical and structured document classification
Documentation progress monitoring
Simplify document submission and approval
Based on TMF Reference Model
Real-time document tracking and management
Main page provides various information at a glance
Convenient Template Management
Configure individual workflows by vendor / document
The convenience of cloud services