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Octalsoft

AI-powered clinical trial management, EDC, IWRS, and eTMF for sponsors, CROs, and research sites.

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Overview

Octalsoft is a clinical trial software company founded in 2007 that develops eClinical and life sciences technology solutions for sponsors, contract research organizations (CROs), and clinical sites. The platform integrates modules including EDC, IWRS, CTMS, eTMF, ePRO/eCOA, and more into a unified system designed to support the full lifecycle of clinical research. Octalsoft reports over 15 years of experience, coverage across 25+ countries, more than 1.5 million lives touched, 40,000+ platform users, 8,000+ clinical sites, and operations spanning 25+ therapeutic areas. For two consecutive years, 2024 and 2025, the company was ranked a "Major Contender" in Everest Group's Life Sciences PEAK Matrix®.

Octalsoft serves the pharmaceutical, biotechnology, and healthcare sectors, offering both purpose-built eClinical products and custom software development services. Its solutions are designed to meet global regulatory compliance standards and support complex, multi-site international trials.

eClinical Solutions

  • Octalsoft CTMS – A cloud-based Clinical Trial Management System providing centralized, real-time data tracking, monitoring, and streamlined study execution.
  • Octalsoft EDC – An Electronic Data Capture platform designed for faster study builds, cleaner datasets, and accelerated time to database lock.
  • Octalsoft IWRS – An Interactive Web Response System supporting randomization, drug supply forecasting, and compliant patient enrollment management.
  • Octalsoft eTMF – An Electronic Trial Master File solution featuring metadata tagging, intelligent workflows, and real-time oversight for regulatory-ready document management.
  • Octalsoft ePRO/eCOA – An Electronic Patient Reported Outcome system for real-time patient data capture and improved trial compliance.
  • Octalsoft rSDV – A Remote Source Data Verification tool aimed at strengthening oversight, reducing monitoring costs, and improving data quality.

Life Sciences Solutions

  • Octalsoft QMS – A Quality Management System for compliance tracking, document control, and automated workflows in regulated life science and healthcare environments.
  • Octalsoft WMS – A Warehouse Management System for storage optimization, inventory tracking, and distribution of clinical and laboratory materials.
  • Octalsoft PPM – A Portfolio and Project Management system for project planning, resource allocation, and real-time progress tracking across multiple trials.
  • Octalsoft LMS – A Learning Management System delivering training modules, compliance certifications, and skill tracking for clinical and healthcare professionals.
  • Octalsoft BMS – A Biorepository Management System providing traceability, storage optimization, and compliance-driven management of biological samples and inventories.
  • Octalsoft HIMS – A Hospital Information Management System for managing patient records, hospital operations, and clinical workflows through integrated digital tools.

Custom Software Development Services

  • Advanced Web Development – Bespoke web applications including SaaS and cloud solutions tailored to pharma organizations, built with scalability and inclusivity in mind.
  • Mobile Application Development – Custom mobile apps for iOS, Android, and Windows platforms, including pharmaceutical software applications built to regulatory standards.
  • Legacy Application Migration – Migration services to move organizations away from outdated systems, including bespoke development for pharma businesses transitioning from legacy infrastructure.
  • Software Product Development – End-to-end product development from inception to go-to-market, including custom pharma software solutions focused on compliance and adaptability.
  • Enterprise Application Integration – Third-party integration services to unify systems and streamline workflows in pharmaceutical and clinical environments.
  • UI/UX Design and Development – User interface and experience design services supporting intuitive navigation and engagement, including for custom pharmaceutical software applications.

Platform and Compliance Highlights

  • All solutions are delivered through a single integrated platform offering real-time data access across trial sites and seamless global reach.
  • The platform is designed to support regulatory adherence across multiple international compliance frameworks.
  • AI and machine learning capabilities are incorporated into the platform to support data-driven decision-making and operational efficiency in clinical trials.
  • Octalsoft serves the pharma, biotech, and healthcare industries, with a stated focus on accelerating drug development and simplifying clinical research operations for sponsors, CROs, and sites.

Octalsoft positions itself as a unified eClinical technology provider, combining a broad suite of purpose-built clinical research modules with custom development capabilities, serving organizations across more than 25 countries and 25 therapeutic areas.

Software

BMS logo
BMS
Centralized biosample tracking, storage management, and lifecycle control with AI-driven insights for regulated biorepositories.
CTMS logo
CTMS
Centralized trial planning, execution, and oversight with real-time dashboards, site management, and financial tracking for global clinical research.
eConsent logo
eConsent
AI-powered electronic informed consent with multimedia forms, adaptive learning quizzes, and real-time compliance oversight for clinical trials.
EDC logo
EDC
Real-time data capture and validation for clinical trials with configurable eCRFs, automated edit checks, and seamless protocol amendments.
eDOCS logo
eDOCS
AI-powered document management with intelligent versioning, compliance tracking, and role-based access for clinical trials.
ePRO logo
ePRO
Real-time capture and AI-driven analysis of patient-reported outcomes for clinical trials, with mobile access and seamless EDC integration.
eTMF logo
eTMF
Centralize, organize, and monitor clinical trial documentation in real time with AI-powered quality checks and regulatory compliance.
IWRS/RTSM logo
IWRS/RTSM
Randomization, drug supply management, and blinding for clinical trials with real-time tracking and predictive inventory optimization.
LIMS logo
LIMS
Centralized lab data management with AI-driven analysis, sample tracking, and regulatory compliance for clinical and pharma labs.
QMS logo
QMS
Centralized quality management for clinical trials with document control, CAPA tracking, compliance automation, and audit readiness.
rSDV logo
rSDV
Remote source data verification with AI-guided monitoring, secure document access, and real-time discrepancy detection for clinical trials.