PPD-SNBL

What PPD-SNBL does

PPD-SNBL (株式会社新日本科学PPD) is a Japan-based Contract Research Organization (CRO) established in April 2015 as a joint venture between Shin Nippon Biomedical Laboratories (SNBL) — which has 60+ years of domestic clinical research heritage dating to 1957 — and PPD (Pharmaceutical Product Development), a global CRO founded in 1985 in the United States. Following Thermo Fisher Scientific's December 2021 acquisition of PPD, PPD-SNBL operates as an indirect subsidiary within Thermo Fisher's PPD segment, serving as the Japan arm of a network spanning 43 countries, 72 development sites, and 35,000+ employees globally. The company provides end-to-end clinical development services for pharmaceutical sponsors across Phase I through Phase IV and post-marketing surveillance, including monitoring, data management, biostatistics, medical writing, regulatory affairs, pharmacovigilance, quality management, GCP audit, and trial startup operations.

The company's service platform rests on four proprietary technology pillars: Preclarus® for integrated multi-source clinical data analysis and visualization, an electronic Trial Master File (eTMF) for document management, Risk-Based Monitoring (RBM) combining on-site, remote, and centralized monitoring with Adaptive and Intelligent Monitoring (AIM), and Decentralized Clinical Trial (DCT) capabilities enabling remote patient participation. PPD-SNBL also offers multi-vendor EDC services spanning Medidata Rave, Veeva Vault EDC, Fountayn, Cube CDMS, and Viedoc, integrated with PPD Laboratories' central testing infrastructure. As of December 2025 the company had 1,044 employees across Tokyo (headquarters), Osaka, and Kagoshima offices, a 95% retention rate, and cumulative experience with approximately 500 clinical trials across broad therapeutic areas.

Revenue is generated through project-based professional services contracts sold via enterprise field sales to Japanese pharmaceutical companies, foreign pharmaceutical companies without Japanese subsidiaries (via In-Country Clinical Caretaker / ICCC services), and Japanese ventures seeking global expansion. The company holds formal partnership contracts with multiple major pharmaceutical sponsors and reports a 100% PMDA-compliance track record on assigned new drug approval trials. Its go-to-market combines direct enterprise B2B sales domestically with PPD network integration for international joint trials, positioning PPD-SNBL to address both Japan-only and global simultaneous drug development. Revenue is not publicly disclosed.

Name

PPD-SNBL

Legal name

株式会社新日本科学PPD

Website

https://ppdsnbl.co.jp

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

501–1,000 employees

Short description

PPD-SNBL (新日本科学PPD) is a Japan-based Contract Research Organization providing full-service Phase I–IV clinical development and post-marketing surveillance to domestic and international pharmaceutical sponsors, operating as the Japan arm of Thermo Fisher's PPD global CRO network.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Health Services (8000)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Global Health Research, Clinical Trials & Product Development Partnerships (PDPs) (HLAJAOAM), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Clinical trial services
• Contract research organization
• Pharmaceutical development
• Clinical monitoring services
• Regulatory affairs services

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Development Services: Full-spectrum CRO services including monitoring, data management, biostatistics, regulatory affairs, medical writing, pharmacovigilance, quality management, GCP audit, and post-marketing surveillance. Revenue generated through project-based professional services contracts with pharmaceutical companies.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

PPD-SNBL (新日本科学PPD) is a Japan-based Contract Research Organization (CRO) delivering full-spectrum clinical development services for pharmaceutical companies. Its offerings span Phase I–IV clinical trials through post-marketing surveillance, including site selection, monitoring, data management, biostatistics, regulatory affairs, medical writing, pharmacovigilance, quality management, and GCP audit. The company combines SNBL's 60+ years of local Japanese clinical expertise with PPD's global network (43 countries, 35,000+ employees) to support both Japan-only and international multi-center clinical trials.

Product overview

PPD-SNBL is a Contract Research Organization (CRO) offering comprehensive clinical development services as a unified platform spanning from Phase I clinical trials through Phase IV post-marketing surveillance. The core technology platform includes Preclarus® for integrated data analysis and visualization, eTMF for electronic document management, RBM (Risk-Based Monitoring) for adaptive monitoring, and DCT (Decentralized Clinical Trial) capabilities for virtual trials. Service modules include Monitoring, Data Management (with EDC services using Medidata Rave, Veeva Vault EDC, Fountayn, Cube CDMS, and Viedoc), Statistical Analysis (Biostatistics and Programming), Medical Writing, Regulatory Affairs, Pharmacovigilance, Quality Management, Medical Monitoring, Start-up Operations (SuO), and GCP Audit. The company leverages its joint venture structure combining Japanese local expertise with global PPD network capabilities to deliver both domestic and international multi-center clinical trials.

Differentiator

Problem solved

Functional benefit

Products and services

• Preclarus® Proprietary global data analysis and visualization system that integrates and standardizes multiple clinical trial data sources (medical institutions, labs, subjects) to provide rapid data collection and visualization for trial sponsors. Used within PPD-SNBL's clinical development service delivery.
• eTMF (Electronic Trial Master File) Electronic document management system for clinical trial-related documents, enabling centralized information management, process automation, improved searchability, and efficient regulatory inspection response. Used within PPD-SNBL's clinical development service delivery.
• Monitoring Services Clinical trial monitoring services including site visits, information transmission, case registration promotion, monitoring report creation, SDV (Source Data Verification), and case report form collection and review. Delivered to pharmaceutical sponsors through dedicated CRA teams with Clinical Team Managers.
• EDC Services Electronic Data Capture (EDC) services using multiple platform options including Medidata Rave, Veeva Vault EDC, Fountayn, Cube CDMS, and Viedoc, for clinical trial data collection with knowledge sharing and backup under PPD Global.
• Data Management Clinical Data Management including CRF/eCRF creation, data review, coding, EDC system setup and support, CDISC/SDTM programming, and database conversion services.
• Statistical Analysis Biostatistics and Programming services including protocol creation support, statistical analysis plan development, CDISC/ADaM data conversion, and advanced methodologies such as Bayesian inference and adaptive designs.
• Medical Writing
• Regulatory Affairs Document creation services including trial protocols, clinical study reports (CSR), CTD for regulatory submission, and medical literature writing.
• Pharmacovigilance
• Quality Management
• Start-up Operation (SuO)
• Medical Monitoring
• GCP Audit
• Phase I to Post-Marketing Surveillance Clinical Trial Services
• Risk-Based Monitoring (RBM) Service
• Decentralized Clinical Trial (DCT) Service

Quantifiable outcome

• All PMDA inspections for assigned new drug approval trials received 'compliant' (適合) evaluations leading to drug approvals
• +5 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration10 records

AI capability2 records

Feature6 records

Partnerships

Four partnerships are on record, tiered minor and core.

• JAC RecruitmentminorGTM or Marketing Partner · 1 October 2025JAC Recruitment conducted a special company feature interview article about PPD-SNBL, published in October 2025, as part of the company's recruitment marketing efforts.
• Pasona (パソナ)minorGTM or Marketing Partner · 1 July 2025Pasona's official YouTube channel featured a day-in-the-life video of a PPD-SNBL female management employee (Clinical Team Leader), published in July 2025, as part of diversity and recruitment promotion content.
• Thermo Fisher Scientific Inc. (via PPD)coreOthers · 1 April 2015PPD (Pharmaceutical Product Development), the global CRO that co-founded PPD-SNBL, was acquired by Thermo Fisher Scientific in December 2021. PPD-SNBL operates as a subsidiary under Thermo Fisher Scientific's group of companies, leveraging the global network and resources of the world's largest science solutions company.
• Shin Nippon Biomedical Laboratories (SNBL)coreStrategic or Co-development Partner · 1 April 2015PPD-SNBL was established as a joint venture combining Shin Nippon Biomedical Laboratories' domestic clinical development expertise (60+ years of Japan CRO leadership) with PPD's global network and systems. SNBL's clinical development division merged with PPD to form the joint venture. PPD-SNBL continues to inherit and leverage SNBL's accumulated domestic knowledge, experience, and quality standards.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• IQVIA Holdings: The world's largest CRO with a major Japan presence. Directly comparable to PPD-SNBL across Phase I–IV clinical trial services, with a substantially larger global footprint and broader commercial/real-world evidence offerings that PPD-SNBL competes against for global joint trial bids.
• ICON plc: Top-five global CRO with significant operations in Japan through its PRA Health Sciences acquisition. Competes with PPD-SNBL for the same enterprise pharmaceutical clients on multi-region Phase II–IV trials and post-marketing surveillance.
• Labcorp Drug Development (formerly Covance): Global CRO with strong central laboratory and clinical development capabilities in Japan. Comparable to PPD-SNBL's combined clinical-plus-lab value proposition and competes for the same pharmaceutical sponsor RFPs.
• Parexel International: Established global CRO with Japan operations providing Phase I–IV clinical development and biostatistics services. Directly comparable in service portfolio and competes for both Japan-only and global joint trials.
• Medpace Holdings: Mid-to-large global CRO with strong Phase II–III capabilities across multiple therapeutic areas. Comparable to PPD-SNBL's clinical development service offering and competes for global joint trials involving Japan sites.
• Syneos Health: Global CRO offering clinical development and commercial services with Asia-Pacific presence. Competes with PPD-SNBL on full-service clinical trials and on integrated clinical-plus-commercial offerings for pharma sponsors.

Direct peers

• CMIC Holdings: Japan's largest domestic CRO, offering Phase I–IV clinical trial services and Site Management Organization (SMO) operations. The most direct domestic competitor to PPD-SNBL for Japanese pharmaceutical sponsors and local-only trials.
• EPS Holdings: Leading Japanese CRO and SMO group providing clinical development, data management, and statistical analysis. Directly competes with PPD-SNBL for local Japan trials and is a key comparable for Japan-only CRO economics.
• Linical: Japan-headquartered CRO with global operations specializing in oncology and clinical development. Closely comparable to PPD-SNBL's growing oncology global trial portfolio and competing for similar foreign pharma Japan entry engagements.

Emerging players

• Worldwide Clinical Trials: Mid-sized global CRO with strong CNS, oncology, and rare disease therapeutic expertise. Comparable in service scope and competes for global trial bids where PPD-SNBL serves as the Japan regional delivery arm.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@ppd-snbl

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 PPD-SNBL