Octalsoft
Octalsoft is a leading provider of innovative eClinical solutions with over 15 years of experience, dedicated to transforming clinical trials through advanced technology. Their mission is to streamline, improve, and accelerate clinical research by offering comprehensive, secure, and customizable software solutions that enhance data management, trial efficiency, and regulatory compliance. They aim to empower CROs, pharma, biotech, and healthcare organizations to conduct more efficient, accurate, and patient-centric clinical trials, leveraging cutting-edge technologies such as AI, ML, cloud computing, and risk-based monitoring.
Industries
Nr. of Employees
medium (51-250)
Octalsoft
Products
Clinical Trial Management System (CTMS)
Software to manage study setup, site and investigator tracking, subject enrollment, visit scheduling, budgeting and reporting across clinical programs.
Electronic Data Capture (EDC) system
Configurable eCRF platform with real-time validation rules, edit checks, query management and audit trails to support source data capture and database lock.
Interactive Web Response System / RTSM
Web-based randomization and trial supply management tool providing stratified randomization, allocation concealment and site-level dispensing controls.
Electronic Trial Master File (eTMF)
Regulatory document management system implementing TMF taxonomy, metadata, milestones and checklists to enable inspection-ready trial documentation.
Electronic patient-reported outcome (ePRO) platform
Patient-facing delivery and reminder system with encrypted, timestamped capture, forced-response controls and EDC connectivity to support timely and complete PRO collection.
Clinical trial supply management (CTSM)
Tooling for lifecycle management of investigational product including packaging, labeling, shipping, allocation and resupply across sites with support for blinded shipments.
Clinical Trial Management System (CTMS)
Software to manage study setup, site and investigator tracking, subject enrollment, visit scheduling, budgeting and reporting across clinical programs.
Electronic Data Capture (EDC) system
Configurable eCRF platform with real-time validation rules, edit checks, query management and audit trails to support source data capture and database lock.
Interactive Web Response System / RTSM
Web-based randomization and trial supply management tool providing stratified randomization, allocation concealment and site-level dispensing controls.
Electronic Trial Master File (eTMF)
Regulatory document management system implementing TMF taxonomy, metadata, milestones and checklists to enable inspection-ready trial documentation.
Electronic patient-reported outcome (ePRO) platform
Patient-facing delivery and reminder system with encrypted, timestamped capture, forced-response controls and EDC connectivity to support timely and complete PRO collection.
Clinical trial supply management (CTSM)
Tooling for lifecycle management of investigational product including packaging, labeling, shipping, allocation and resupply across sites with support for blinded shipments.
Services
SaaS suite combining CTMS, EDC, RTSM/IWRS, eTMF, ePRO and analytics for end-to-end trial operations from study setup to closeout.
End-to-end design and delivery of configurable enterprise applications and integrations tailored to clinical and operational workflows.
Integration of ML models and analytics pipelines to automate data processing, predict operational risks and generate actionable insights for trial teams.
Deployment and configuration of RBM workflows, risk indicators, alerting and analytics to prioritize monitoring and reduce on-site verification burden.
Implementation and integration of remote data capture, eConsent, ePRO and remote monitoring to support hybrid and fully decentralized study designs.
Project management, user onboarding, training programs, validation documentation and ongoing technical support to ensure adoption and regulatory readiness.
SaaS suite combining CTMS, EDC, RTSM/IWRS, eTMF, ePRO and analytics for end-to-end trial operations from study setup to closeout.
End-to-end design and delivery of configurable enterprise applications and integrations tailored to clinical and operational workflows.
Integration of ML models and analytics pipelines to automate data processing, predict operational risks and generate actionable insights for trial teams.
Deployment and configuration of RBM workflows, risk indicators, alerting and analytics to prioritize monitoring and reduce on-site verification burden.
Implementation and integration of remote data capture, eConsent, ePRO and remote monitoring to support hybrid and fully decentralized study designs.
Project management, user onboarding, training programs, validation documentation and ongoing technical support to ensure adoption and regulatory readiness.
Expertise Areas
- Clinical trial management and site operations
- Electronic data capture and clinical data management
- Randomization and trial supply management (RTSM/CTSM)
- Decentralized clinical trials and remote monitoring
Key Technologies
- Artificial intelligence and machine learning
- Risk-based monitoring analytics
- Electronic data capture (EDC) / eCRF
- ePRO / eCOA platforms
News & Updates
Octalsoft is participating in the DIA 2025 Global Annual Meeting in Washington, DC, from June 15–19, showcasing their solutions.
An overview of recent technological and best practice advancements in data management for CROs, including AI, real-time monitoring, and security.
Octalsoft is participating in the DIA 2025 Global Annual Meeting in Washington, DC, from June 15–19, showcasing their solutions.
An overview of recent technological and best practice advancements in data management for CROs, including AI, real-time monitoring, and security.