Electronic Trial Master File eTMF Software

Clinevo electronic Trial Master File (eTMF) is an easy to use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.

Clinevo electronic Trial Master File (eTMF) has inbuilt DIA reference model and meets regulatory guidelines including:

Digital Content Archiving,
Security and Access Control,
Change Controls,
Audit Trails and
System Validation

Inbuilt & Configurable DIA TMF Structure

Clinevo electronic Trial Master File (eTMF) software comes with a prebuilt DIA reference model & also allows organizations to define their own / Sponsor specific TMF structure

File Planning & Milestones Setup

Clinevo electronic Trial Master File (eTMF) software allows companies to create a File /Study Plan along with milestones at the study level, country level, and site level.

Live Tracking of Missing Documents

Based on the file plan, Clinevo electronic trial master file (eTMF) system tracks the status of the documents & monitors the TMF compliance at every level.

Document Lifecycle and Version Control

Clinevo electronic Trial Master File (eTMF) is one of the best eTMF software which has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

Advanced Analytics

Clinevo electronic Trial Master File (eTMF) System is the best eTMF that provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

Bulk / Quick upload with Dynamic Indexing

Clinevo electronic Trial Master File (eTMF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

External Systems Integration

Clinevo electronic Trial Master File (eTMF) software is the best eTMF that can be Integrated with CDMS/ CTMS systems to get the study, site, patient and other information and dynamically create Directory structure.

Sharing and Collaboration

Clinevo electronic Trial Master File (eTMF) System allows users to invite external parties to upload and work collaboratively on documents in a controlled method

Faster User Adoption

Business TeamS, CROs, Site personnel, External Vendors and others can be trained on the Clinevo electronic Trial Master File (eTMF) System within few hours

Anytime, Anywhere & Any device

Clinevo electronic Trial Master File (eTMF) System is the best user friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

Regulatory Inspection Ready

Clinevo electronic Trial Master File (eTMF) System complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

Extendable Document Management System

Clinevo electronic Trial Master File (eTMF) System is the best eTMF that can be used as a focused eTMF or as a general document management system for the clinical trials.