LINEA System

LINEA System is a clinical trial site selection and activation platform founded in 2008 by Kathleen Colatrella, RPh, MS, with a background in clinical research and medical affairs at Roche, Genta, and MannKind. The company develops AI-powered tools designed to replace relationship-driven and assumption-based site selection with verified, continuously updated performance data. LINEA serves pharmaceutical sponsors and CROs seeking to reduce study startup timelines and improve enrollment outcomes by identifying, ranking, and activating investigative sites more systematically.

The platform is built around two core products: the Research Site Index (RSI), an investigator intelligence database, and AcceleTrial, a workflow execution system for managing the full site activation lifecycle. Together, these tools are intended to take a sponsor from protocol upload through to first patient enrolled within a governed, data-driven operating model.

Research Site Index (RSI)

• Contains 250,000+ investigator records spanning 186 countries, 109 specialties, and 44,000+ distinct US institution labels.
• Records are refreshed monthly, with real-time updates available on request, supported by validation-backed source persistence and quality controls.
• Scores investigators and sites against protocol-specific criteria across dimensions including population fit, investigator experience, operational readiness, diversity, and geographic coverage.
• Supports 12 UI languages for global sponsor and operations teams.
• Described by LINEA as the only continuously verified database of US clinical research sites scored across 12 performance dimensions with sponsor-relationship history.
• Enables sponsor teams to search investigators, deduplicate site lists, generate targeted outputs, and build feasibility packages from a single platform.

AcceleTrial Platform

• Manages site activation workflow, document controls, SLA logic, reporting, and role-based workspaces across sponsor, CRO, site, regulatory, finance, and audit roles.
• Scores every site across seven protocol-specific dimensions: population fit, investigator experience, operational readiness, diversity, geographic coverage, enrollment reliability, and protocol compatibility.
• Includes geographic network mapping to visualize site density, competitive enrollment pressure, and patient population proximity across any indication and geography.
• Provides enrollment forecasting through predictive modeling, surfacing sites most likely to meet enrollment targets based on protocol requirements and verified historical performance.
• Offers complete investigator profiles covering credentials, publication history, active trial load, and prior sponsor relationships.
• Automates feasibility outreach through digital questionnaires and real-time response scoring, replacing manual feasibility coordination.
• Tracks contract milestones, budgets, agreements, and startup milestones end-to-end across a site portfolio from a single dashboard.

How the Platform Works

• Sponsors upload a protocol document; the AI extracts therapeutic area, indication, phase, and enrollment targets and configures the scoring engine automatically.
• LINEA's AI scores the full RSI against the protocol and returns a ranked, verified site list within minutes.
• Feasibility questionnaires are sent automatically, with AI scoring responses against the protocol as they are received.
• Contracts, budgets, and regulatory milestones are then governed end-to-end through first patient enrolled.

Reported Outcomes

• Study startup timelines compressed by up to 50% when beginning with the right sites and protocol-aware activation workflow.
• 96% of targeted sites approved by the sponsor and ultimately included in a study, per the AcceleTrial fact sheet.
• One sponsor achieved 100% enrollment of 177 patients randomized, four months ahead of schedule.
• A rare disease sponsor activated 9 specialist sites within 4 months.
• LINEA System was recognized by MD Tech Review for advancements in clinical study startup technology.

Company Background and Certifications

• Founded in 2008; relaunched in 2018 as an AI-powered site selection and engagement platform.
• Certified as a Minority/Women-Owned Business Enterprise (MWBE) by the State of New Jersey in 2021.
• Leadership includes Founder and President Kathleen Colatrella, President of Sponsor and CRO Solutions Bruce K. Gould, CFO Mark Haft, Director of Product Management and Clinical Solutions Hamita Patel, and Director of Project Management Kathleen Haft.
• Board of Advisors includes Laurie Myers (COO, Cingulate Therapeutics), Patrick Healy (Co-Founder and President, Trial Runners), and Faisal Alshalawi (Fund Manager, Alinma Investment Company).

LINEA System is headquartered in New Jersey and positions its RSI and AcceleTrial platform as an integrated operating model for sponsors and CRO operations teams seeking to reduce site selection guesswork and accelerate clinical trial startup through data-governed processes.