Linical

What Linical does

Linical is a Japan-headquartered, publicly listed global Contract Research Organization (CRO) founded in 2005 and operating across more than 30 countries in the Americas, Europe, and Asia Pacific. The company provides full-service clinical development support to mid-sized biotechnology and biopharmaceutical sponsors, covering the full trial lifecycle from drug development strategy and protocol design through regulatory affairs, clinical monitoring, patient recruitment, biometrics, and pharmacovigilance, with therapeutic depth in oncology, neurology and psychiatry, immunology and vaccines, endocrinology and metabolic disorders, and other focus areas including biosimilars, rare disease, and pediatrics.

The company's operational platform rests on conventional clinical trial management systems and CRO infrastructure rather than proprietary AI tooling, with internal assets including a Training Academy for workforce development, real-time data cleaning processes for regulatory submission quality, and patient recruitment solutions. It holds ISO/IEC 27001 information security certification, has completed over 600 studies in the past five years, and reports that more than 80% of its studies beat enrollment goals, that client retention exceeds 85%, and that employee retention exceeds 80%.

Linical monetizes exclusively through professional services engagements, with quote-based, project-priced contracts and multi-year billing cadences determined by study scope, therapeutic complexity, phase, geography, and enrollment targets. Go-to-market is direct enterprise field sales supported by thought-leadership content, industry events, and a Request-a-Proposal intake funnel. The company is publicly listed on the Tokyo Stock Exchange under ticker 2183:JP and is led by President & CEO Kazuhiro Hatano. A new Functional Services Provider offering is listed as 'Coming Soon' and would extend the portfolio beyond full-service outsourcing into flexible functional staffing.

Name

Linical

Legal name

Linical

Website

https://linical.co.jp

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Linical is a Japan-headquartered, publicly listed global CRO providing full-service clinical development, regulatory affairs, biometrics, and pharmacovigilance services to mid-sized biotechnology and biopharmaceutical sponsors across 30+ countries.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Clinical research organization
• Drug development services
• Clinical trial management
• Regulatory affairs services
• Pharmacovigilance solutions

Headquarters

HQ city

Osaka-shi

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Organization Services: Full-service CRO providing comprehensive clinical development services including drug development strategy, clinical trial management, regulatory affairs, and functional service provider solutions. Revenue generated through project-based contracts with pharmaceutical and biotechnology companies across Americas, Europe, and Asia Pacific.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Linical is a global Contract Research Organization (CRO) that provides full-service clinical development services for pharmaceutical and biotechnology sponsors. Its offerings span drug development strategy (protocol design, regulatory affairs, quality assurance, medical writing, regulatory consulting) and clinical trial management (feasibility, project management, clinical monitoring, patient recruitment, biometrics, pharmacovigilance), delivered across therapeutic areas including oncology, neurology & psychiatry, immunology & vaccine, endocrinology & metabolic, and rare disease / pediatrics. Revenue is generated via project-based, quote-priced multi-year contracts with mid-sized biotech and biopharmaceutical companies across 30+ countries.

Product overview

Linical is an award-winning, global Contract Research Organization (CRO) offering a comprehensive, full-suite platform of clinical development services. The portfolio consists of two primary service pillars: Drug Development Strategy (including Protocol Development & Study Design, Regulatory Affairs, Regulatory Consulting, Quality Assurance, and Medical Writing) and Clinical Trial Management (covering Feasibility & Study Start Up, Project Management, Medical Affairs & Pharmacovigilance, Clinical Monitoring, Patient Recruitment, Biometrics, and Training Academy). A Functional Services Provider offering is also listed as Coming Soon. The company provides therapeutic expertise across Oncology, Neurology & Psychiatry, Immunology & Vaccine, Endocrinology & Metabolic, and Other Focus Areas (Biosimilars, Rare Disease, Pediatrics), operating across Early Phase, Phase II-III, and Late Phase clinical trial stages globally.

Differentiator

Problem solved

Functional benefit

Products and services

• Drug Development Strategy Strategic planning service for pharmaceutical and biotechnology sponsors that develops customized clinical trial plans, proactively tackles obstacles, optimizes trial design, and positions trials for regulatory success. Includes sub-services for protocol development and study design, regulatory consulting, regulatory affairs, quality assurance, and medical writing.
• Clinical Trial Management Comprehensive full-range CRO service for pharmaceutical and biotechnology sponsors covering patient recruitment, data capture, and safety regulation navigation. Encompasses feasibility and study start-up, project management, medical affairs and pharmacovigilance, clinical monitoring, patient recruitment, biometrics (statistical analysis, data management, bioinformatics), and the internal Training Academy for workforce development.
• Oncology Therapeutic Services Specialized clinical trial services for oncology sponsors, including solid tumors, liquid tumors, immunotherapies, rare cancers, and early phase oncology studies, for pharmaceutical and biotechnology clients.
• Neurology & Psychiatry Therapeutic Services Specialized clinical trial services for CNS diseases including cognitive, neurological, movement, mood, and neuromuscular disorders, as well as pain management, for pharmaceutical and biotechnology clients.
• Immunology & Vaccine Therapeutic Services Specialized clinical trial services for immunology, including prophylactic and therapeutic vaccines, outbreak and epidemic response, allergic and autoimmune disorders, and respiratory diseases, for pharmaceutical and biotechnology clients.
• Endocrinology & Metabolic Therapeutic Services Specialized clinical trial services for endocrinology and metabolic disorders, including diabetes, thyroid disorders, reproductive disorders, and inherited disorders, for pharmaceutical and biotechnology clients.
• Other Focus Areas (Biosimilars, Rare Disease, Pediatrics) Specialized clinical trial services for biosimilars, rare disease, and pediatrics, for pharmaceutical and biotechnology clients.
• Early Phase Studies Clinical trial services for early phase (Phase I) studies delivered for pharmaceutical and biotechnology sponsors.
• Phase II-III Studies Clinical trial services for mid-stage (Phase II-III) studies delivered for pharmaceutical and biotechnology sponsors.
• Late Phase Studies Clinical trial services for late phase (Phase IV) studies delivered for pharmaceutical and biotechnology sponsors.

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators6 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Medpace Holdings: US-based mid-to-large full-service CRO with comparable operating model — full-service clinical development for biopharma with strong therapeutic specialization. Most directly comparable peer given overlap in mid-sized sponsor targeting and study phase mix.
• Clinipace Worldwide: Mid-market CRO offering full-service clinical development with therapeutic focus in oncology, gastroenterology, and rare disease — comparable scale and customer profile to Linical.
• Worldwide Clinical Trials: Privately-held global CRO offering full-service Phase I–IV clinical development with strong therapeutic expertise in neuroscience, oncology, and rare disease — directly comparable in size, service model, and therapeutic mix to Linical.
• Premier Research: Specialty CRO focused on biotech and mid-sized pharma with deep expertise in rare disease, oncology, and CNS — competes head-to-head for the same mid-cap sponsor RFPs as Linical.
• Advanced Clinical (now part of Avantor): Mid-sized clinical research services provider with comparable therapeutic expertise and full-service CRO capabilities — overlapping target customer segment (mid-sized biotech/biopharma).

Broad incumbents

• ICON plc: One of the largest global CROs post-PRA Health acquisition, offering full-service clinical development plus FSP and lab services — competes for large enterprise biopharma contracts where Linical also bids, but at materially greater scale.
• IQVIA: Largest global CRO and life sciences services firm — overlaps with Linical across clinical operations and regulatory services, but at vastly greater scale and with proprietary technology/data assets Linical lacks.
• Syneos Health: Global biopharmaceutical solutions organization combining CRO and contract commercial services — broader scope than Linical but directly competes in clinical trial management and FSP service lines.
• Fortrea Holdings: Spun off from Labcorp in 2023 as a pure-play global CRO — competes directly with Linical for clinical trial management contracts across Phase I–IV with comparable full-service portfolio.

Regional players

• EPS Holdings (Japan): Leading Japanese CRO with similar Asia-Pacific roots and services — directly comparable to Linical in Japanese market and increasingly in Asia-Pacific clinical trial execution for global sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/linical-korea

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Linical