What Linea System does

LINEA System is a privately held, founder-owned software company headquartered in Parsippany, New Jersey, that builds AI-powered tooling for clinical trial site selection and activation. Its platform combines two products: the Research Site Index (RSI), a continuously refreshed proprietary database of more than 248,000 investigator records spanning 186 countries, 228 specialties, and 43,000+ US institution labels; and AcceleTrial, a workflow execution system that automates feasibility outreach, CDA execution, contract milestone tracking, regulatory document collection, and role-based reporting from protocol-defined site ranking through first patient enrolled. The company serves pharmaceutical sponsors, contract research organizations, and biotech sponsors running trials in rare or novel indications, with an explicit focus on the site start-up phase of clinical operations where enrollment delays are most acute.

The underlying technology combines structured data processing (investigator records, trial parameters, historical performance) with natural language processing of protocol documents and feasibility questionnaires. AI scoring evaluates each candidate site across seven protocol-specific dimensions (population fit, investigator experience, operational readiness, diversity, geographic coverage, enrollment reliability, and protocol compatibility), with a specialized adjacent-indication methodology for rare-disease and novel-modality trials. The platform supports 12 UI languages and produces traceable decision documentation to support sponsor audit and compliance requirements.

LINEA sells exclusively through an enterprise field sales motion targeting VP-level and above clinical operations leadership at top pharma, mid-size biotech, and global pharma companies. The standard engagement is an 8–12 week site identification and activation workflow priced under negotiated multi-year enterprise agreements, with an optional managed-services extension covering regulatory document collection, IRB submission support, and site initiation preparation through first patient screened. Pricing is not publicly disclosed. Founded in 2008 by Kathleen Colatrella and relaunched in 2018 as an AI-native platform, LINEA remains a small, bootstrapped company with a reported headcount of 1–10 and no institutional funding rounds disclosed.

Name

Linea System

Legal name

LINEA System, LLC

Website

https://lineasystem.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

1–10 employees

Short description

LINEA System builds an AI-powered site selection and activation platform for pharmaceutical sponsors, CROs, and biotechs, combining a 248,000+ investigator database (RSI) with a workflow execution system (AcceleTrial) to accelerate clinical trial start-up.

Ownership category

akta.pro rank

Product category

Clinical Trial Site Selection Software

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

akta.pro secondary industries

Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ), Clinical Trial Site Operations & Study Coordination (HLAGACAE)

Keywords

• Clinical trial site selection
• Investigator intelligence platform
• Site activation workflow
• Clinical trial feasibility
• Pharma sponsor analytics

Headquarters

HQ city

Parsippany

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. AcceleTrial Platform Subscription: Access to the AcceleTrial site activation workflow platform and Research Site Index is provided to authorized customers under separate written agreements (order form, master services agreement, and applicable product terms). The core engagement covers site identification, CDA execution, feasibility screening, and delivery of a qualified site list. An extended activation track is available as a separate scope for sponsors needing deeper support through first patient screened.
2. Extended Activation Scope: Extended engagement covering regulatory document collection, IRB submission support, site initiation preparation coordination, and timeline monitoring through first patient screened. Scoped separately from core AcceleTrial engagement.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

LINEA System provides an AI-powered investigator intelligence and site activation platform for pharmaceutical sponsors and CROs. The Research Site Index (RSI) is a continuously refreshed database of 248,000+ investigator records across 186 countries and 228 specialties, scored against protocol-specific criteria. AcceleTrial is the companion workflow execution platform that manages feasibility outreach, CDA execution, regulatory document collection, contract milestones, and reporting from ranked site list delivery through first patient enrolled.

Product overview

LINEA System offers a two-product platform for AI-powered clinical trial site selection and activation. The core offering consists of the Research Site Index (RSI), an investigator intelligence database with 248,000+ AI-scored investigator records across 186 countries and 228 specialties, which feeds directly into AcceleTrial—a governed workflow execution platform that automates feasibility outreach, document controls, contract milestone tracking, and site activation from site ranking through first patient enrolled. RSI serves as the intelligence layer that provides verified, protocol-aware site scoring, while AcceleTrial serves as the execution layer that transforms ranked site lists into governed activation workflows.

Differentiator

Problem solved

Functional benefit

Brands

• Research Site Index (RSI): An AI-scored database of 248,000+ investigator records spanning 186 countries and 228 specialties, providing verified intelligence for clinical trial site selection.
• AcceleTrial

Products and services

• Research Site Index (RSI) An AI-powered investigator intelligence database of 248,000+ investigator records spanning 186 countries, 228 specialties, and 43,000+ US institution labels. Each investigator is scored against protocol-specific criteria across seven dimensions (population fit, investigator experience, operational readiness, diversity, geographic coverage, enrollment reliability, and protocol compatibility). Monthly data refresh with real-time updates on request, validation-backed source persistence, and 12-language UI for global sponsor and operations teams. Serves pharmaceutical sponsors and CROs as the intelligence layer for clinical trial site selection.
• AcceleTrial A site activation workflow execution platform for pharmaceutical sponsors and CROs. Manages site activation workflow, document controls, SLA logic, reporting, and role-based workspaces across sponsor, CRO, site, regulatory, finance, and audit roles. Capabilities include automated feasibility questionnaires with AI response scoring, contract milestone tracking, geographic network mapping, enrollment forecasting, investigator profile intelligence, and protocol document ingestion that auto-configures the scoring engine. Delivered as the activation layer that turns the RSI's ranked site list into governed execution through first patient enrolled, with engagement timelines of 8–12 weeks to a qualified site list for 20–40 site studies.

Quantifiable outcome

• Up to 50% faster trial start-up timeline when beginning with the right sites and protocol-aware activation workflow
• +7 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 capability7 records

Feature10 records

Scale indicators8 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Advarra: Advarra provides site activation, IRB review, and clinical technology services to pharma sponsors and CROs — directly comparable to LINEA's site activation and regulatory workflow focus.
• Inato: Inato is a direct competitor offering an AI-driven clinical trial site selection and activation platform that matches sponsors with qualified investigator sites globally — closely aligned with LINEA's RSI and AcceleTrial value proposition.
• Florence Healthcare: Florence Healthcare provides electronic Investigator Site File (eISF) and site activation workflow software for sponsors, CROs, and sites — directly competing with AcceleTrial's document control and activation lifecycle capabilities.
• Trial Runners: Trial Runners is a site management organization (SMO) that activates and manages trial sites for sponsors — directly comparable to LINEA's site activation workflow focus, and notably founded by LINEA Board Advisor Patrick Healy.

Broad incumbents

• Veeva Systems: Veeva's Vault CTMS and Vault SiteVault offerings address clinical operations, site management, and document workflows across pharma sponsors — adjacent to LINEA's AcceleTrial execution layer with a much broader enterprise footprint.
• IQVIA: IQVIA is the largest CRO and clinical technology provider, offering site identification, feasibility, and study activation services as part of its broader portfolio — overlapping with LINEA's core offering but bundled with EDC, CTMS, and full-service CRO capabilities.
• Medidata (Dassault Systèmes): Medidata provides the Rave clinical trial platform used by most large pharma sponsors, including site management, EDC, and trial design tools — overlapping with LINEA's site intelligence and activation workflow layer.
• WCG (WIRB-Copernicus Group): WCG offers IRB services, site activation support, and clinical trial enablement technology across the sponsor and CRO ecosystem, with overlapping reach in site feasibility and startup acceleration.

Emerging players

• Castor: Castor offers an EDC and clinical trial platform with site management and ePRO capabilities, increasingly used by sponsors for decentralized and hybrid trial execution — an emerging alternative in the same workflow category.
• ObvioHealth: ObvioHealth is a digital CRO that uses technology to run decentralized and hybrid trials, with site identification and patient recruitment workflows that overlap with LINEA's site activation thesis.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Linea System