Electronic Trial Master File (eTMF)

An electronic trial master file is a specialized content management system used to manage clinical documents; collection of essential documents such as IEC Approved Protocol, Information Boucher (IB), CRF, ICD, CV, Insurance Certificate, etc., across the life cycle of a clinical trial – conducting of a clinical trial to be reconstructed and evaluated

It allows life science companies to streamline processes, automate information exchange, and reduce administrative overhead associated with running clinical trials

Trial Master File (or electronic TMF; eTMF) solution is a clinical knowledge platform for managing clinical trial documents. It essentially is digital capturing, managing, sharing and storing those essential documents and content from clinical trials

eTMF enables complete sponsor and investigator site files to be rapidly created for each study and helps to ensure readiness for audits and inspections.

Sarjen Systems offers an exclusive combination of eTMF technology, quality and services to deliver a range of flexible, targeted solutions to the clinical research industry

Key Benefits

eTMF application

Suite for multidesign & multiphase trial projects

Streamlined key business processes through integrated workflows

Provision for configurable metadata

Faster search and retrieval of documents

Ensured file structure and organizing

Advance engine to manage documents in various formats

Integrated PDF viewer

Maintained visibility, status and control of trial documentation

Comprehensive archiving and retrieving

Accessibility and Compliance

User Friendly, Web based application

Part 11 compliant (21 CFR Part 11 and Annex 11)

Flexible rights management

Access control (role and scope based)

Reduced regulatory risk

Cost savings from increased filing efficiency and reduced paper

eTMF module provides

Dynamic template structure management

Drag and drop functionality for document upload

Tracking dashboards for bird’s eye view of projects, submissions, more…

Track status and location of documents

Using eTMF, get the following functionalities

Sponsor audit profile

HTML and PDF merge & publish

Published document formatting – Bookmarks, Header, Footer & Title page generation

Generate automatic Table of Content (TOC) with hyperlinks

Produce Certified copies

Regulatory compliant, multi-functional Clinical trials management software solution for CROs