What Regulus does

Regulus Inc. (レギュラス株式会社) is a Tokyo-based, privately-held medical imaging contract research organization (CRO) that delivers specialized imaging core lab services for clinical trials conducted by pharmaceutical companies, medical device manufacturers, and investigator-led research groups. The firm provides an end-to-end, six-step workflow (STEP1-6) covering imaging procedure documentation, photography consulting, anonymized image data transfer, image quality control, central image adjudication committee management, quantitative image analysis on workstations, and final report delivery. Each step can be contracted individually or as a full package, supplemented by a remote image central adjudication service introduced in 2021 that allows diagnostic radiologists to evaluate trial images without physical travel.

The company is staffed by approximately 15 full-time employees, including licensed radiological technologists with prior hospital clinical experience, supported by a curated network of 54 diagnostic radiologists across therapeutic areas including oncology, cardiovascular, respiratory, and urology. Regulus has accumulated roughly 15 years of operational history (originating from a predecessor imaging-focused CRO around 2008-2009), reporting 165+ commissioned projects and 121+ clinical trial protocols completed across Japan with stated capability to support global studies.

The business operates on a project-based professional services model with custom, multi-year contracts priced according to scope; pricing is not publicly disclosed. The go-to-market is direct enterprise sales targeting pharma clinical development teams, medical device regulatory affairs groups, and academic investigators, conducted primarily in Japan with a domestic focus on the Kanto region. On June 21, 2024, Regulus became a wholly-owned subsidiary of PSP Corporation (PSP株式会社) as part of a strategic business and capital partnership, while continuing to operate as an independent service provider.

Name

Regulus

Legal name

Regulus Inc. ( レギュラス株式会社 )

Website

https://cro.co.jp

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

1–10 employees

Short description

Regulus is a Tokyo-based medical imaging CRO providing end-to-end imaging core lab services, including central adjudication and remote reading, for clinical trials run by pharmaceutical companies, medical device manufacturers, and academic researchers in Japan.

Ownership category

akta.pro rank

Product category

Medical Imaging CRO / Clinical Research Services

NAICS

Scientific Research and Development Services (5417)

SIC

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

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Medical imaging CRO
• Clinical trial imaging
• Central image adjudication
• Imaging core lab services
• Radiology adjudication services

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, Infrastructure, Marketing or Sales

Revenue model

1. 医用イメージングCROサービス (Imaging CRO Services): Project-based services for pharmaceutical companies, medical device manufacturers, and research institutions. Services include central image adjudication committees, image data management, photography consultation, and image analysis. Projects can be contracted as full end-to-end packages (STEP1-6) or individual services.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels2 records

Core offering

Regulus provides specialized medical imaging contract research organization (CRO) services for pharmaceutical, medical device, and clinical research clients. The offerings cover the full imaging workflow—from protocol/photography manual creation, shooting consulting, data transfer and anonymization, image quality control, and central image adjudication committee management to quantitative image analysis and final report delivery. Services can be purchased as individual workflow steps or as an integrated end-to-end package, with a remote image central reading option for distributed adjudication.

Product overview

Regulus is a specialized medical imaging CRO (Contract Research Organization) offering integrated imaging core lab services for clinical trials and clinical research. The company operates as a single unified service platform with a modular six-step workflow (STEP1-6) covering imaging protocol development, shooting consulting, data transfer, quality control, central image reading management, and image analysis. The core Medical Imaging CRO Services serve as the primary offering, supplemented by a Remote Image Central Reading Service for remote evaluations. Clients can engage individual steps or the full end-to-end service package.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Imaging CRO Services (医用イメージングCRO業務) A specialized contract research organization service focused on medical imaging for clinical trials, providing end-to-end support from imaging protocol setup through central image reading and analysis for pharmaceutical companies, medical device manufacturers, and research institutions.
• Remote Image Central Reading Service (遠隔画像中央判定サービス) A remote-based image central adjudication service that allows radiologists and physicians to evaluate medical images without physically traveling to a centralized location, reducing costs and providing flexible scheduling for image central reading committee meetings in pharmaceutical, medical device, and investigator-initiated clinical trials.

Quantifiable outcome

• 165+ commissioned projects completed nationally
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators7 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Medpace: Medpace is a global CRO with in-house imaging core lab capabilities serving mid-sized pharmaceutical and biotech sponsors. Its full-service model and therapeutic area expertise in oncology, cardiovascular, and metabolic diseases compete with Regulus's specialty focus.
• Clario (formerly Bioclinica): Clario is a global leader in clinical trial imaging and endpoint solutions, formed through the merger of Bioclinica and ERT. It is the dominant imaging CRO globally and competes directly with Regulus in medical imaging core lab services, though at a much larger scale and with broader geographic coverage.
• Parexel: Parexel is a major global CRO offering comprehensive clinical development services including imaging capabilities. It competes with Regulus for pharmaceutical sponsor work, particularly for international trials where Parexel's global footprint offers advantages.
• ICON plc: ICON plc is one of the world's largest CROs, having acquired PRA Health Sciences, and offers imaging services through its dedicated Medical Imaging group. It competes with Regulus for global pharmaceutical trial imaging work, particularly for large Phase III programs.
• IQVIA: IQVIA is the world's largest CRO and life sciences services provider, offering imaging core lab services through its dedicated technology and analytics functions. It competes broadly with Regulus for global pharmaceutical sponsor imaging work, especially for large integrated trial programs.

Direct peers

• CMIC Holdings: CMIC is Japan's largest CRO, offering comprehensive clinical development services including imaging support. As a domestic peer with full-service trial capabilities, CMIC competes with Regulus for Japanese pharmaceutical clients, though Regulus's pure-play imaging focus is its differentiation.
• Imaging Endpoints: Imaging Endpoints is a specialized global imaging CRO providing image analysis, central reading, and reader management for oncology clinical trials. It is a direct competitor in the pure-play imaging CRO space where Regulus operates, with broader therapeutic focus on oncology.
• EPS Holdings: EPS Holdings is a major Japanese CRO providing clinical trial support services including imaging-related services to pharmaceutical companies. It is a direct competitor in the Japanese market with broader service offerings across the clinical development lifecycle.
• Bell Medical Solutions: Bell Medical Solutions is a Japanese CRO focused on clinical trial support including medical imaging services. It is a direct domestic competitor to Regulus with overlapping customer base among Japanese pharmaceutical companies and similar specialization in imaging-related CRO services.

Emerging players

• Median Technologies: Median Technologies provides imaging solutions for oncology clinical trials, including AI-based image analysis. As an emerging imaging-focused company with technology emphasis, it represents both a competitor and adjacent player to Regulus's imaging CRO services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

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 Regulus