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Core Capabilities of Octalsoft eDOCS

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Centralized Digital Repository

  • Secure, cloud-based document management software accessible anytime, anywhere.
  • AI-driven categorization and metadata tagging for instant retrieval.
  • Supports all trial document types (regulatory, site, patient, operational).
  • Provides consistency across global, multi-site studies.
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Intelligent Version Control

  • Automated versioning prevents outdated or duplicate files.
  • AI detects discrepancies between versions for quality assurance.
  • Full audit trails capture edits, approvals, and e-signatures.
  • Ensures compliance with ICH-GCP, 21 CFR Part 11, and EMA standards.
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Seamless Collaboration

  • Role-based access for sponsors, CROs, and sites.
  • AI identifies workflow bottlenecks in reviews and approvals.
  • Real-time alerts keep teams aligned across geographies.
  • Reduces delays in regulatory and operational submissions.
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Automated Compliance Tracking

  • AI flags missing, expired, or non-compliant documents.
  • Automated reminders for renewals (IRB approvals, CVs, training records).
  • Instantly generates audit-ready reports.
  • Simplif
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eSignatures & Secure Authentication

  • Supports legally binding e-signatures.
  • AI-powered identity verification ensures security.
  • Fully compliant with FDA, EMA, HIPAA, GDPR.
  • Eliminates costs of paper storage, printing, and manual filing.
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Resources That Speak
for Octalsoft eDOCS

eClinical Suite Case Study

eClinical Suite Case Study

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Factsheet – Electronic Document Management System (eDOCS)

Factsheet – Electronic Document Management System (eDOCS)

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What is eDocs Used For?
2 min read

What is eDocs Used For?

In the ever-evolving world of clinical research, digital transformation is no longer a luxury — it’s a necessity. Among the...

Enhance Your eDOCS
with These Powerful Add-ons

eConsent

Octalsoft eConsent

Store and track patient consents directly within eDocs.

Explore eCONSENT
CTMS

Octalsoft CTMS

Link trial documents to milestones for true operational oversight.

Explore CTMS

Key Benefits for Every Role
in Your Clinical Trial

Sponsors

Gain complete visibility and control over all trial documents with centralized oversight. Minimize compliance risks through automated audit trails and version control. Accelerate regulatory and ethics submissions with streamlined document workflows.

CROs

Standardize documentation processes across studies and clients for consistent quality. Leverage AI-driven dashboards to proactively identify and resolve compliance issues. Save time with automated document categorization, tagging, and filing.

Site Teams

Simplify documentation, reduce administrative workload, and stay audit-ready at all times. Focus more on patient care and trial execution—less on paperwork.

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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