Product Overview
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
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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
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.
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
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.
About the company
Founded in 2016, we are a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. We help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involves Data warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence.
With our unique combination of domain experience & technology expertise, we are committed towards delivering the most efficient and the best practical end-to-end software solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other applicable regulatory guidelines. Our unmatchable domain experience and technology expertise enables us to deliver the best software solutions.