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Core Capabilities of Octalsoft eTMF

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Centralized Trial Documentation

  • Cloud-based repository for all trial master file documents.
  • AI-powered categorization and indexing for fast, reliable retrieval.
  • Pre-mapped to the DIA eTMF Reference Model for standardization.
  • Scales effortlessly across Phase I–IV and global, multi-site studies.
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AI-Driven Quality & Completeness Checks

  • Automated QC to meet regulatory and protocol standards.
  • AI flags missing, incomplete, or duplicate records.
  • Risk-based scoring highlights compliance gaps for faster remediation.
  • Supports continuous audit and inspection readiness.
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Intelligent Version Control & Audit Trail

  • Secure version management with controlled access.
  • AI detects unauthorized edits and inconsistencies.
  • Comprehensive audit trail captures every change, approval, and e-signature.
  • Fully compliant with 21 CFR Part 11, ICH-GCP, HIPAA, and GDPR.
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Seamless Collaboration Across Stakeholders

  • Role-based access ensures secure sponsor–CRO–site collaboration.
  • Automated workflows streamline document review and approval cycles.
  • Real-time notifications keep trial teams aligned.
  • Reduces bottlenecks in submissions and monitoring.
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Real-Time Oversight & Analytics

  • Custom dashboards track trial progress and TMF health metrics.
  • AI-driven analytics predict compliance risks proactively.
  • Automated reporting accelerates decision-making and submissions.
  • Supports both sponsors and CROs with transparent oversight.
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Resources That Speak
for Octalsoft eTMF

eClinical Suite Case Study

eClinical Suite Case Study

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Factsheet – Electronic Trial Master File (eTMF)

Factsheet – Electronic Trial Master File (eTMF)

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How to Optimize the Electronic Trial Master File (eTMF)
6 min read

How to Optimize the Electronic Trial Master File (eTMF)

The management of clinical trial documents increasingly becomes essential to ensure compliance, transparency, and hence less findings by regulatory authorities....

Enhance Your eTMF
with These Powerful Add-ons

eDOCS

Octalsoft eDocs

Synchronize trial documents with your TMF for streamlined oversight

Explore eDOCS
CTMS

Octalsoft CTMS

Connect TMF compliance with trial milestones and operational insights.

Explore CTMS

Key Benefits for Every Role
in Your Clinical Trial

Sponsors

Ensure global compliance with real-time visibility and centralized document oversight. Enhance TMF quality and maintain continuous inspection readiness across all studies.

CROs

Standardize documentation processes across multiple sponsors for improved efficiency. Scale effortlessly while minimizing administrative workload and compliance risks.

Site Teams

Simplify document management and stay aligned with sponsor requirements. Reduce manual effort and maintain audit-ready documentation without added burden.

Why Choose Octalsoft?

expertise

Domain Expertise

With decades of combined experience in clinical research technology, our team understands the needs of CROs, Sponsors, and Sites.

integrated

All-in-One Platform

From planning and operations to data capture and analytics - we deliver integrated platforms for every stage of the trial lifecycle.

regulatory

Regulatory Ready

Our systems are designed to meet global regulatory standards such as 21 CFR Part 11, GCP, and GDPR, ensuring compliance at every level.

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24/7 Support

We offer personalized onboarding, 24/7 support, and ongoing optimization services to ensure long-term success for your studies.

Simplifying Clinical trials
From Complexity To Clarity

One Platform, Complete Control

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