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Electronic Trial Master File Software (eTMF)

Octalsoft eTMF solution provides functionality to effectively manage the lifecycle of all clinical trial regulated content. An efficient way to maintain regulatory compliant Trial Master File by organizing & storing documents, images & other content of your TMF electronically is ensured by this solution.

The Octalsoft eTMF Software System

Along with a seamless integration with CTMS application, the eTMF software allows you to effectively manage and control your entire Clinical Trials operations by providing appropriate role based access controls and real-time insights. The complete audit trail of the digital content streamlines the workflows with ensured quality controls at every stage

Features & Benefits of Octalsoft Electronic Trial Master Software

  • Seamless integration with CTMS application
  • Wizard Driven process for setup
  • TMF Reference Model for standardized processes
  • Automated workflows for quality reviews & document finalizations
  • Multilayered security for data & application
  • Role-based Access control for additional safety
  • Interactive Reporting with self-service approach
  • Effective management and control on entire Clinical Trials operations
  • Powerful search engine for fast access to documents.
  • Easy sort documents from views, queries & statistics
Octalsoft eTMF – digitize your Trial Master File
Transparent, Standardized, Compliant.

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Product Overview

Wizard Driven

Flexible wizard driven process for setting up eTMF table of contents, meta data and other parameters simplifies maintaining of Trial Master File across all the clinical trials.

TMF Reference Model based

Standardize eTMF ToC by defining required and optional documents during the initial set up process.  Allows flexibility to add study specific documents.

Workflow Enabled

Automate the quality review and document finalization process.   Online document viewer facilitates document review and finalization process.

Highly Secured

Provides multi-layered security across database and application.  Implement data encryption, user controls, usage analysis, and conditional auditing to meet compliance requirements

Role-based Access

Octalsoft eTMF allows you to define role-based access control.  Each user will have just enough access to the data/document that he needs to perform his function.

Interactive Reporting

Allows end users to modify their own data layouts without requiring any help from the IT team.  Each user can rearrange a report’s data and save multiple layouts for later reference.

Features & Benefits of Octalsoft Electronic Trial Master Software

Achieve Standardization

Standardize Trial Master File content and processes across all studies

Ensure Compliance

Real-time insight into the status of your documents helps you identify missing and overdue documents for appropriate action

Real-time Reporting

Up-to-date reports of TMF status and quality keeps you Audit-ready at any time

Process Automation

Integrated Workflow, email notifications, and alerts helps you automate and streamline processes

Maintain Single Source

One unified database to store, organize and distribute your TMF documents means everybody is working off of the same information.

Lower Trial Costs

Reduction in redundant system and processes shortens the entire clinical trial lifecycle

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