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

System Validation

Comprehensive Solution

Comprehensive Pharmacovigilance Solution

Clinevo Pharmacovigilance Software is a powerful, AI-driven drug safety database designed to streamline case processing, ensure compliance, and provide advanced analytics for pharmaceutical companies, CROs, and regulatory teams.

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.

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.

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

Efficiency Optimization

Efficiency & Cost Optimization

Clinevo Safety is built on a simplified technology stack, ensuring cost-effectiveness, easy maintenance, and faster user adoption.

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

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.

Regulatory Inspection Ready

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

Smart Insights

Smart Insights & Accessibility

Clinevo Pharmacovigilance Software offers intelligent analytics and real-time compliance alerts while ensuring seamless access from anywhere.

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

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.

Why Choose Clinevotech's Software Solutions?

Global Trust

Clinevo tech’s software solutions are trusted by life sciences, pharmaceutical, biotech, and CRO clients across the USA, the UK, Europe, Korea, Japan, China and India.

Compliance-Driven

Built with industry regulations, our software includes automated compliance checks, robust audit trails, and tools to ensure adherence to guidelines and standards.

Cost-Effective

Reduce the need for infrastructure and manual processes. Our cloud-based software provides an efficient and affordable solution tailored to your needs.

End-to-End Process Management

From initial setup to final reporting, our software supports every stage of your workflow, ensuring organized, compliant, and up-to-date process management.

Expert Support

Our experienced team offers dedicated support for implementation, training, and ongoing assistance, ensuring the success of your operations.