Clinflash eTMF

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Electronic Trial Master File
Clinflash eTMF
Building a complete, standardized and professional clinical data management library for users
A complete, standardized, and professional Electronic Trial Master File systemBy embedding the goal of standardizing documentation quality at all stages of a clinical trial and efficiently connecting sponsors, CROs and sites, Clinflash eTMF enables visualization of key risk factors to monitor and manage project documentation in real time. It supports DIA reference model, complies with GCP, and maximizes compliance with FDA 21 CFR Part 11 and NMPA standards for quality management of clinical trial documents in the fields of drugs, devices, vaccines, truly standardizing the process of clinical trials with high efficiency, and building a complete, standardized, and professional supply chain of clinical data for users.Clinflash eTMF has provided personalized document management solutions to more than 60 innovative pharmaceutical companies since its launch in 2019
Advantages of Clinflash eTMF
01High upload efficiency
Drag-and-drop upload of documents in batches
Uploads based on schedule files
Placeholder-based uploads
02Quality assurance
Instant quality control of document quality
Online follow-up issue document
In-depth analysis of quality reports
03Standardized management
Standardized directory management
Standardized process management
Standardized document naming management
04Risk control
Full evaluation of compliance indicators
Early warning of risks
Visual risk management
01High upload efficiency
Drag-and-drop upload of documents in batches
Uploads based on schedule files
Placeholder-based uploads
02Quality assurance
Instant quality control of document quality
Online follow-up issue document
In-depth analysis of quality reports
03Standardized management
Standardized directory management
Standardized process management
Standardized document naming management
04Risk control
Full evaluation of compliance indicators
Early warning of risks
Visual risk management
Clinflash system connection and integration for intelligent interaction
of multiple systems with eTMF as the core
Automatically synchronize project information in CTMS and support users to automatically synchronize uploading/archiving of project documents/reports
Support users to learn courses within the training system/project, to greatly improve users’ operational efficiency while maintaining the unity of business data in multiple systems
Automatically synchronize the associated eCTD filing documents to eCTD for users to add/replace synchronously
Support multi-system linkage to avoid duplication of labor and to save user’s time
Clinflash system connection and integration for intelligent interaction
of multiple systems with eTMF as the core
Automatically synchronize project information in CTMS and support users to automatically synchronize uploading/archiving of project documents/reports
Automatically synchronize the associated eCTD filing documents to eCTD for users to add/replace synchronously
Support users to learn courses within the training system/project, to greatly improve users’ operational efficiency while maintaining the unity of business data in multiple systems
Support multi-system linkage to avoid duplication of labor and to save user’s time
Core features of Clinflash eTMF
Document management
Support folder and document attribute management functions, and allow for the development of sampling rules based on project needs to complete the full cycle of closed-loop document quality control
Online collaboration
Control specific members to edit multi-format documents online at the same time through permissions, and support to view edit traces and historical versions
Comprehensive tracking
Support online viewing, efficient retrieval and export, multi-level operation log viewing to meet the needs of users at all levels, and full-scenario operation trace recording in the system
Custom functions /reports
Custom approval processes and different templates, and customize viewing and exporting functions through multi-dimensional visualization charts
File plan management
Support fast batch creation of plan file lists, summarize different scenarios and support real-time viewing of missing lists, give intelligent email alerts for uploading/archiving, and visualize report analysis and export
Efficient transmission
Support multiple file uploading methods, batch uploading, as well as fast uploading and downloading of large-capacity files (client)
System integration
Support independent management of project information from CTMS, and maintain efficient connection with CTMS/eCTD/eLearning to synchronize different information in real time
TMF configuration
Support one-click import by folder catalog templates, as well as quick granting of document permissions by user/user group and reference permission templates
Core features of Clinflash eTMF
Document management
Support folder and document attribute management functions, and allow for the development of sampling rules based on project needs to complete the full cycle of closed-loop document quality control
Online collaboration
Control specific members to edit multi-format documents online at the same time through permissions, and support to view edit traces and historical versions
Comprehensive tracking
Support online viewing, efficient retrieval and export, multi-level operation log viewing to meet the needs of users at all levels, and full-scenario operation trace recording in the system
Custom functions /reports
Custom approval processes and different templates, and customize viewing and exporting functions through multi-dimensional visualization charts
File plan management
Support fast batch creation of plan file lists, summarize different scenarios and support real-time viewing of missing lists, give intelligent email alerts for uploading/archiving, and visualize report analysis and export
Efficient transmission
Support multiple file uploading methods, batch uploading, as well as fast uploading and downloading of large-capacity files (client)
System integration
Support independent management of project information from CTMS, and maintain efficient connection with CTMS/eCTD/eLearning to synchronize different information in real time
Comprehensive minimalist and practical dashboards, with personalized and visual report export
PART 1
Modular dashboards to filter source data in real time according to user needs
PART 3
Real-time visualization charts, offering more intuitive data
PART 2
Multi-dimensional charts monitor document collection to identify missing documents instantly, to improve management transparency
PART 4
Complete compliance with the requirements of all scenarios on the dashboard
Comprehensive minimalist and practical dashboards, with personalized and visual report export
PART 1Modular dashboards to filter source data in real time according to user needs
PART 2Multi-dimensional charts monitor document collection to identify missing documents instantly, to improve management transparency
PART 3Real-time visualization charts, offering more intuitive data
PART 4Complete compliance with the requirements of all scenarios on the dashboard
Clinflash CTMS
Clinflash eCTD
Clinflash EDC
The leading provider of digital solutions and professional services in field of clinical development
Company Hotline:400-803-8655
Business Cooperation:bd@clinflash.com
Technical Support:edchelp@clinflash.com
Jiaxing Office:3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRC
Shanghai Office:Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. China
Hangzhou Office:16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
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Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550Privacy PolicyService Levels (SLA)System Node Policy
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The leading provider of digital solutions and professional services in field of clinical developmentCompany Hotline:400-803-8655Business Cooperation:bd@clinflash.comTechnical Support:edchelp@clinflash.comJiaxing Office:3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRCShanghai Office:Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. ChinaHangzhou Office:16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
Clinflash official account
Privacy PolicyService Levels (SLA)
Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550
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