What DOT World does

DOT World (DOTワールド株式会社) is a Tokyo-based Japanese contract research organization (CRO) that provides end-to-end clinical trial support services for pharmaceutical companies, medical device manufacturers, academic medical institutions, venture-backed developers, and non-life-sciences companies entering the healthcare market. Founded on November 7, 2006, as DOT International and renamed DOT World in 2017, the company has accumulated 200-plus physician-initiated trial and clinical research support cases, more than 40 corporate-sponsored trials, 40-plus medical-device trials including SaMD, and at least 40 rare-disease trials, contributing to 10-plus product market approvals. Its service portfolio is structured around four core lines — investigator-initiated trial and specified clinical research support, corporate-sponsored clinical development, software as a medical device (SaMD) clinical development, and medical market entry support — supplemented by specialist service modules for clinical research associate (CRA/monitoring), data management, statistical analysis, and medical writing. CDISC Gold Member status underpins global regulatory submission capability, including SDTM and ADaM mapping.

The company operates a B2B professional services model with quote-based project pricing tied to trial scope, therapeutic area, and duration. Multi-year contracts are typical, and revenue mechanics depend on the mix of small investigator-initiated trials, mid-sized SaMD engagements, and larger enterprise-sponsored programs. Sales and demand generation run through a consultative approach anchored by a free initial consultation, supplemented by participation in industry events (BioJapan, DIA Japan, Japanese Society of Clinical Pharmacology, BIO International Convention), academic conferences, and relationship-based referrals. DOT World maintains a single headquarters in Tokyo's Minato-ku (NBF Comodio Shiodome building) and is led by CEO Hiroko Iijima (飯島寛子), who assumed the role on August 1, 2018, with Katsuhiro Kuriyama (栗山勝宏) serving as Chairman.

DOT World is a subsidiary of World Intec Co., Ltd. (株式会社ワールドインテック), itself a business unit under the publicly listed conglomerate World Holdings (株式会社ワールドホールディングス, Tokyo Stock Exchange First Section). The company integrated with World Intec on November 1, 2012, and is wholly owned within the group structure with no external institutional or venture capital exposure. Regulatory credentials include Privacy Mark certification from JIPDEC (December 3, 2015), associate membership in the Japan CRO Association (July 2009), and a US alliance with ClinDatrix, Inc. (February 27, 2014) supporting global trials conducted in Japan. The primary operating geography is Japan, with selective international engagement through alliance and conference participation.

Name

DOT World

Legal name

DOTワールド株式会社

Website

https://crodot.jp

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

DOT World is a Tokyo-based Japanese contract research organization providing investigator-initiated trials, corporate-sponsored clinical development, SaMD, and medical market entry support to pharmaceutical, medical device, academic, and non-life-sciences entrants.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) / Clinical Research Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Clinical trial services
• Contract research organization
• Drug development support
• Medical device clinical development
• Regulatory affairs consulting

Headquarters

HQ city

Tokyo

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, Others

Revenue model

1. CRO Clinical Development Services: DOT World provides contract research organization (CRO) services on a project-by-project basis. Services span trial planning, monitoring, data management, statistical analysis, medical writing, regulatory affairs, and PMDA consultation. Revenue is generated through project fees structured around the scope and complexity of clinical trial support engagements. Pricing is quote-based and varies by trial scale, therapeutic area, and scope of services.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

DOT World operates as a Contract Research Organization (CRO) providing end-to-end clinical trial support services for drugs, medical devices (including SaMD/Program Medical Devices), and regenerative medicine products. Core offerings include investigator-initiated trial support, corporate-sponsored clinical development, SaMD clinical development, and medical market entry support for non-life-sciences companies entering healthcare. Services span trial planning, monitoring, data management, statistical analysis, medical writing, regulatory affairs, and PMDA consultation.

Product overview

DOT World operates as a CRO (Contract Research Organization) offering a unified suite of clinical trial support services organized around four core offerings: investigator-initiated trial support, corporate clinical development support, SaMD (Software as a Medical Device) clinical development, and medical market entry support. These core services are supplemented by specialized service modules including data management, statistical analysis, clinical research associate (monitoring) services, and medical writing. The company leverages a group-wide network within World Holdings to provide comprehensive clinical development support from study planning through regulatory submission, positioning itself as a flexible partner for both academic institutions and commercial sponsors.

Differentiator

Problem solved

Functional benefit

Products and services

• Investigator-Initiated Trial / Specified Clinical Research Support (医師主導治験・特定臨床研究支援) Comprehensive support for physician-initiated clinical trials and specified clinical research, including research secretariat operations, data management, statistical analysis, monitoring, auditing, and medical writing services. Designed for academic physicians, university hospitals, and medical institutions conducting investigator-initiated trials with over 100 cases of support experience.
• Corporate Clinical Development Support (企業主導臨床開発支援) Full-spectrum support for company-sponsored clinical trials, encompassing study design, monitoring, data management, statistical analysis, medical writing, and regulatory consultation for pharmaceutical and biotech companies. Targets companies ranging from large enterprises to emerging ventures with limited internal clinical development capacity.
• SaMD Clinical Development Support (プログラム医療機器臨床開発支援) Specialized clinical development support for Software as a Medical Device (SaMD/Program Medical Device) products, including regulatory strategy, protocol design, GCP-compliant system setup, and recruitment strategy formulation. Serves venture companies and startups facing distinct regulatory challenges in SaMD clinical development.
• Medical Market Entry Support (医療の市場参入支援) Comprehensive support for medical market entry encompassing GCP compliance preparation, SOP development, organizational structure setup, PMDA consultation, and project progress management. Designed for companies from outside life sciences (e.g., automotive, technology) seeking to enter the medical/healthcare market.
• Data Management (データマネジメント) Clinical trial data management services including Electronic Data Capture (EDC) system setup, Case Report Form (CRF) review, data entry, and data cleaning operations to ensure high-quality data throughout study execution. Supports both investigator-initiated and corporate-sponsored trials.
• Statistical Analysis (統計解析) Statistical analysis services for clinical trials and clinical research, including statistical analysis plan creation, analytical methodology selection, and programming for statistical computations. A university professor of biostatistics serves as advisor for continuous learning and application of latest methodology.
• Clinical Research Associate / Monitoring (CRA / 臨床開発モニター) Clinical trial site management and monitoring services, including site qualification assessment, investigator selection, and post-trial progress management to ensure GCP compliance throughout the trial lifecycle.
• Medical Writing (メディカルライティング) Medical writing services for clinical development documentation of drugs and medical devices, including clinical trial protocols (治験実施計画書) and clinical study reports (治験総括報告書). Supports regulatory submissions, journal manuscripts, and academic clinical research outputs.

Quantifiable outcome

• Over 200 accumulated physician-initiated trial and clinical research support cases
• +5 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• 国立大学法人高知大学 (Kochi University)coreStrategic or Co-development Partner · 16 December 2021DOT World entered a business partnership with Kochi University (National University Corporation) on December 16, 2021. This partnership enables collaboration on clinical research and clinical trial support between DOT World and the university's medical faculty, expanding DOT World's access to academic clinical research opportunities.
• 松山晃文教授 / 藤田医科大学 (Prof. Akifumi Matsuyama, Fujita Health University)minorOthers · 5 November 2018DOT World entered an advisory contract with Prof. Akifumi Matsuyama (Professor of Regenerative Medicine, Director of Regenerative Medicine Support Facility, Research Support Promotion Center, Fujita Health University). Prof. Matsuyama provides expert advisory input in the regenerative medicine domain, enhancing DOT World's capabilities in this specialized therapeutic area.
• 株式会社クリニカルトラスト (Clinical Trust Co., Ltd.)minorStrategic or Co-development Partner · 13 April 2015DOT World entered a strategic partnership with Clinical Trust Co., Ltd. as a strategic monitoring business partner for clinical trial monitoring services. This partnership extends DOT World's monitoring capacity and capabilities through collaboration with a specialized monitoring partner.
• ClinDatrix, Inc. (クリンダトリクス社)coreStrategic or Co-development Partner · 27 February 2014DOT World entered an alliance partnership with US-based CRO ClinDatrix (California, founded 2002, with 20+ years of clinical development expertise and strong capabilities in global data management). This partnership enables DOT World to more smoothly operate global trials conducted in Japan by serving as an alliance partner for the US market. ClinDatrix brings global trial expertise and US regulatory knowledge that complements DOT World's domestic capabilities.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Mediscience Planning: Japanese CRO with established physician-led trial and pharmacovigilance practice. Comparable offering set for academic and pharmaceutical sponsors in Japan.
• EPS Holdings: Major Japanese CRO providing comprehensive clinical development, data management, biostatistics, and medical writing services. Directly competes with DOT World across investigator-initiated and corporate-sponsored trial support in Japan.
• A2 Healthcare Corporation: Japanese CRO specializing in clinical trial services, including support for medical device and SaMD development. Closely matches DOT World's customer segments, particularly investigator-initiated studies and medical device sponsors.
• CMIC Holdings: Japan’s largest domestic CRO offering full-service clinical trial support including SMO, monitoring, data management, and regulatory consulting. Direct peer serving overlapping pharmaceutical, biotech, and academic sponsors in Japan.
• Linical (formerly MediciNova K.K. CRO division): Japan-headquartered CRO with operations spanning US/EU and strong oncology/experimental design expertise. Direct competitor for pharmaceutical and biotech clinical development outsourcing from Japan.

Broad incumbents

• IQVIA Japan: Global tier-1 CRO with substantial Japan operations, offering end-to-end clinical and real-world evidence services. Competes with DOT World on enterprise-sponsored trials while DOT World addresses smaller, more flexible engagements.
• Worldwide Clinical Trials (Japan): Global mid-sized CRO with Japan presence focused on complex therapeutic-area trials. Comparable in service mix to DOT World but at broader scale and with deeper therapeutic-area footprint.
• Syneos Health Japan: Global CRO with presence in Japan providing clinical and commercial services. Represents the established international competitor profile that DOT World targets against for niche and mid-size Japanese engagements.

Emerging players

• Inotiv (formerly BASi): Smaller contract research and preclinical services provider competing for niche laboratory and clinical research engagements. Adjacent peer for outsourced life sciences work.

Regional players

• Peace and Mind (PA&M) CRO: Japanese CRO offering clinical trial monitoring, data management, and biostatistics. Comparable focus on domestic pharmaceutical and academic sponsors.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 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 DOT World