Octalsoft

What Octalsoft does

Octalsoft is a privately held clinical trial software company that delivers a unified, cloud-based eClinical platform for the life sciences industry. Founded in 2007 and headquartered in Herndon, Virginia, with its primary delivery center in Ahmedabad, India, the company integrates CTMS, EDC, IWRS/RTSM, eTMF, ePRO/eCOA, eConsent, rSDV, eDOCS, Imaging, and CTSM into a single architecture designed to eliminate data silos across clinical operations. The platform is built on AWS infrastructure with Oracle integration support and is compliant with FDA 21 CFR Part 11, ICH-GCP, GDPR, and HIPAA. It also offers a Lifescience Solutions portfolio (QMS, WMS, PPM, LMS, LIMS, BMS, HIMS) and a Custom Software Development service.

The company's go-to-market is enterprise-led, using direct field sales, demo-driven engagement, and industry event sponsorship (ISCR, SCDM, DIA) to target pharmaceutical companies, biotechnology firms, CROs, and hospitals. Revenue is generated through SaaS subscription licensing for the unified platform and module suite, supplemented by professional services for implementation, customization, and bespoke software development. The company claims roughly 40,000 users across 8,000+ clinical sites in 25+ countries, with over 1.5 million lives touched through trials supported by its platform, and has been recognized as a Major Contender in the Everest Group Life Sciences PEAK Matrix for two consecutive years (2024 and 2025).

Octalsoft positions AI/ML as a core platform differentiator, offering Agentic AI for risk-based quality management, predictive analytics for enrollment and site performance, anomaly detection, NLP-driven medical coding, and generative AI for protocol and Clinical Study Report generation. Ownership appears to remain with founders and management (CEO Hiren Thakkar); the company has no disclosed institutional funding rounds, subsidiaries, or M&A activity in the public record, indicating a capital-efficient, bootstrapped growth posture.

Name

Octalsoft

Legal name

Octalsoft Solutions Private Limited

Website

https://octalsoft.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

101–250 employees

Short description

Octalsoft is a privately held clinical trial software vendor offering a unified, cloud-based eClinical suite (CTMS, EDC, IWRS, eTMF, ePRO, eConsent, rSDV, imaging) with embedded AI/ML capabilities, serving pharmaceutical companies, biotech firms, CROs, and hospitals across 25+ countries from its Herndon and Ahmedabad offices.

Ownership category

akta.pro rank

Product category

eClinical Software

NAICS

Computer Systems Design and Related Services (5415), Custom Computer Programming Services (541511), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (51821)

SIC

Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370), Services-Computer Programming Services (7371)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Clinical Trial Management Systems (CTMS) (HLACAOAD), Randomization & Trial Supply Management (RTSM/IRT/IVRS/IWRS) (HLACAOAC), eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB)

Keywords

• Clinical trial software
• EClinical solutions
• Electronic data capture
• Clinical trial management
• Life sciences software

Headquarters

HQ city

Herndon

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Software Subscription (SaaS): Cloud-based subscription model for accessing the unified eClinical platform and its integrated modules including CTMS, EDC, IWRS, eTMF, ePRO, eConsent and other solutions. Pricing likely tiered by study volume, user seats, or module access.
2. Professional Services: Implementation, customization, and consulting services for deployment of clinical trial software solutions including custom software development for pharma organizations.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Octalsoft provides a unified cloud-based eClinical platform that integrates clinical trial management (CTMS), electronic data capture (EDC), interactive web response systems (IWRS/RTSM), electronic trial master file (eTMF), electronic patient-reported outcomes (ePRO/eCOA), electronic consent (eConsent), remote source document verification (rSDV), electronic documents (eDOCS), imaging, QMS, and CTSM modules for pharmaceutical companies, biotech firms, CROs, and hospitals to run clinical trials end-to-end. The company also delivers complementary solutions such as LIMS, BMS, HIMS, WMS, LMS, PPM, and AI/ML-powered analytics, plus custom software development services for life sciences clients.

Product overview

Octalsoft delivers a dual-portfolio platform-plus-modules architecture combining eClinical Solutions and Lifescience Solutions. The eClinical Suite (including CTMS, EDC, IWRS/RTSM, eTMF, ePRO/eCOA, eConsent, rSDV, eDOCS, Imaging, and CTSM) provides an integrated platform for clinical trial operations from study startup to database lock. The Lifescience Solutions portfolio (including QMS, WMS, PPM, LMS, LIMS, BMS, and HIMS) extends the platform for enterprise-wide operational management. The AI/ML-Driven eClinical Suite adds Agentic AI, predictive analytics, and intelligent automation capabilities across all modules. Custom Software Development services complement the product suite with bespoke solutions for specific client requirements. The platform is positioned as a unified ecosystem rather than standalone tools, enabling seamless data flow and unified workflows across clinical and operational functions.

Differentiator

Problem solved

Functional benefit

Products and services

• Unified eClinical Suite (Octalsoft eClinical Platform) Unified SaaS platform combining clinical trial management, electronic data capture, randomization, trial master file, patient-reported outcomes, electronic consent, remote SDV, electronic documents, imaging, QMS, and CTSM for pharma, biotech, CROs, and hospitals.
• Octalsoft CTMS (Clinical Trial Management System) Module for managing clinical trial operations including study planning, milestones, subject tracking, monitoring, and reporting for sponsors and CROs.
• Octalsoft EDC (Electronic Data Capture) Module for designing eCRFs and capturing clinical trial subject data with edit checks, query management, and audit trails compliant with 21 CFR Part 11.
• Octalsoft IWRS / RTSM Module providing subject randomization, treatment assignment, and investigational product supply management for clinical trials.
• Octalsoft eTMF (Electronic Trial Master File) Module for storing, organizing, and managing essential clinical trial documents required for regulatory inspections and submission.
• Octalsoft ePRO / eCOA Module for capturing patient-reported outcomes electronically through diaries and questionnaires in clinical trials.
• Octalsoft eConsent Module for electronic informed consent capture, workflow management, and audit-ready consent records at investigator sites.
• Octalsoft rSDV (Remote Source Document Verification) Module for remote source document verification, enabling monitors to review source records without on-site visits.
• Octalsoft eDOCS (Electronic Document Management) Module for organizing, storing, and retrieving clinical trial documents and records across the study lifecycle.
• Octalsoft Imaging (Medical Imaging Management) Module for centralized capture, storage, and review of medical imaging data used as clinical trial endpoints.
• Octalsoft QMS (Quality Management System) Module providing quality and compliance workflows such as CAPA, deviations, and audits for clinical and operational teams.
• Octalsoft CTSM Module for clinical trial supply management, shipment tracking, and investigational product logistics.
• Octalsoft LIMS (Laboratory Information Management System) Module for managing laboratory samples, results, and workflows associated with clinical studies.
• Octalsoft BMS (Bio-analytical Management System) Module for bioanalytical sample tracking, study data, and laboratory workflows.
• Octalsoft HIMS (Hospital Information Management System) Module for managing hospital and clinical research operations, including patient records and clinical research workflows.
• Octalsoft WMS (Warehouse Management System) Module for warehouse and inventory management of clinical supplies used in trials.
• Octalsoft LMS (Learning Management System) Module for training, certification, and learning management for clinical and operational staff.
• Octalsoft PPM (Project Portfolio Management) Module for managing portfolios of clinical projects, resources, budgets, and timelines.
• AI/ML-Powered Capabilities (Agentic AI) AI/ML and agentic AI capabilities that automate clinical workflows, data review, and insights across the Octalsoft product suite.
• Custom Software Development Services Professional services offering custom software design, integration, and implementation for life sciences organizations across pharma, biotech, CRO, and hospital segments.

Quantifiable outcome

• 20-30% of trial cost tied to inefficient data management (industry benchmark)
• +1 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability11 records

Feature6 records

Partnerships

Two partnerships are on record, tiered core and supporting.

• AWS (Amazon Web Services)coreTechnology or IntegrationAWS serves as the cloud infrastructure provider for Octalsoft's eClinical platform, enabling scalable, secure cloud-based deployment of clinical trial software solutions.
• OraclesupportingTechnology or IntegrationOracle technology integration referenced as part of Octalsoft's technology stack, supporting platform interoperability and data management capabilities.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medrio: Cloud-based EDC, ePRO, and eConsent platform targeting mid-market sponsors and CROs. Closely comparable to Octalsoft in customer profile and product breadth.
• RealTime Software Solutions: Site-focused eClinical suite (CTMS, eDOCS, eRegulatory, eSource) used by hospitals, CROs, and research sites. Comparable to Octalsoft's site and hospital segment.
• ArisGlobal: Life sciences technology platform offering CTMS, eTMF, RBQM, and safety solutions. Comparable to Octalsoft in mid-market and enterprise pharma segments.
• Bio-Optronics: Provides Clinical Conductor CTMS and eClinical solutions for sites, sponsors, and CROs. Overlaps with Octalsoft particularly on CTMS and operational tooling.
• Castor: Cloud-based eClinical platform covering EDC, eCOA, eConsent, and decentralized trial capabilities. Competes head-to-head with Octalsoft in mid-market and academic sponsor accounts.

Broad incumbents

• Medidata (Dassault Systèmes): Industry-leading eClinical platform offering Rave EDC, CTMS, eCOA, RTSM, and analytics. Most direct head-to-head competitor to Octalsoft at the largest enterprise tier.
• Veeva Systems: Provides Veeva Vault CTMS, eTMF, and Vault Clinical Operations targeting large pharma. Competes with Octalsoft on CTMS and eTMF, particularly in enterprise accounts.
• Oracle Health Sciences: Offers Oracle Clinical One, EDC, RTSM, and CTMS as part of a broader health sciences suite. A broad incumbent competing across multiple Octalsoft product lines.
• Clario: Provides eCOA, cardiac safety, imaging, and clinical trial technology services. Overlaps with Octalsoft on eCOA, ePRO, and imaging modules.

Emerging players

• Florence (formerly Complion): Specializes in eRegulatory and eTMF solutions for clinical research sites and sponsors. Partial overlap with Octalsoft's eTMF and eDOCS modules.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/Octalsoft_
• YouTubeyoutube.com/channel/UC-myGhsMcxgIRqIND_8JTyw
• Facebookfacebook.com/Octalsoft
• LinkedInlinkedin.com/company/octalsoft
• Instagraminstagram.com/octalsoft

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Octalsoft