What Mediscience Planning does

Mediscience Planning Inc. (株式会社メディサイエンスプラニング, "MPI") is a Japan-based, full-service Contract Research Organization (CRO) founded in 1982, operating as a wholly-owned subsidiary of M3, Inc. — a Tokyo Stock Exchange Prime-listed company (Nikkei 225 component). The company provides comprehensive clinical development support to pharmaceutical, biotechnology, medical device, and food/health companies across the full drug development lifecycle from Phase I through post-marketing surveillance. Service offerings span 26 categories including clinical trial monitoring (CRA), data management, biostatistics, pharmacovigilance, medical writing, regulatory affairs, medical imaging CRO, CDISC-compliant data conversion, and quality assurance/GCP audits. The company also holds a First-class Medical Device Marketing License (13B1X10366) and IVD Marketing License (13E1X00036).

The company's core technology platform combines proprietary digital trial services (EDC, ePRO, eConsent, eTMF) with structural integration into M3 Group's healthcare IT infrastructure, including m3.com (330,000+ Japanese physicians, 6.5M+ global) and Japan's largest patient databases (3H, Qlife) plus condition-specific recruitment platforms (Oncolo, Rares, Gan Plus, Chiken-kun). Specialized service units include the Global Pharmaceutical Development Center (GPDC) for emerging biopharma market entry into Japan, a Regenerative Medicine Development Support unit, RBQM (Risk-Based Quality Management) solutions aligned with ICH-E6(R3), and AI/Digital Health services supporting SaMD development and AI-enabled imaging diagnostics.

Mediscience Planning generates revenue through professional services fees on a custom/quote-based pricing model, offered either as full-outsource or partial delegation to enterprise pharmaceutical, biotech, and medical device clients. Approximately 60% of studies are global/international in scope. The company operates a Tokyo headquarters with nationwide coverage and holds wholly-owned subsidiary CPOC Co., Ltd. (established 2007), which specializes in CRA monitoring and quality control. The GTM motion is enterprise field sales targeting pharmaceutical manufacturers, with M3 Group's physician platform providing referral and integration advantages unavailable to standalone competitors.

Name

Mediscience Planning

Legal name

株式会社メディサイエンスプラニング

Website

https://mpi-cro.co.jp

Company type

Private

Founded year

1982

Operating status

Operating

Headcount range

251–500 employees

Short description

Mediscience Planning is a Japan-based, full-service CRO (founded 1982) and core subsidiary of M3 Group providing Phase I–IV clinical development, regulatory affairs, pharmacovigilance, and AI/digital health services to pharmaceutical, biotech, and medical device companies, leveraging Japan's largest physician network.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) / Clinical Development Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417), Custom Computer Programming Services (541511)

SIC

Services-Health Services (8000), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Contract research organization
• Clinical trial services
• Drug development support
• Regulatory affairs consulting
• Pharmacovigilance 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, Marketing or Sales, Infrastructure

Revenue model

1. CRO Services - Clinical Development: Full-service Contract Research Organization providing comprehensive clinical development services to pharmaceutical, biotech, and medical device companies. Revenue generated through service fees for monitoring, data management, statistics, pharmacovigilance, medical writing, regulatory affairs, and imaging CRO services.
2. Regulatory Affairs Consulting: Pharmaceutical application support services including approval certification applications, GVP/QMS consulting, and PMDA consultation support. 30+ years of accumulated experience in regulatory affairs.
3. Digital Health and AI Services: AI tools for clinical trial network building, medical image analysis, and digital health solutions integrated with M3 Group's physician platform.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Mediscience Planning Inc. is a full-service Contract Research Organization (CRO) that provides clinical development support to pharmaceutical, biotech, and medical device manufacturers across the entire drug development lifecycle from Phase I through post-marketing surveillance. Core offerings include clinical trial monitoring (CRA), data management, biostatistics, pharmacovigilance, medical writing, regulatory affairs consulting, CDISC-compliant data services, and specialized capabilities such as regenerative medicine development support, SaMD/AI medical device support, RBQM solutions, and imaging CRO. Services are delivered through proprietary digital trial platforms (EDC, ePRO, eConsent, eTMF) integrated with M3 Group's physician network and patient databases.

Product overview

Mediscience Planning operates as a full-service Contract Research Organization (CRO) providing comprehensive clinical development support. The portfolio includes core monitoring and data services (CRA, Data Management, Biostatistics), regulatory consulting, pharmacovigilance, medical imaging CRO, and specialized services (Regenerative Medicine, AI/Digital Health, SaMD). Services are delivered through the company's proprietary digital trial platform (EDC, ePRO, eConsent, eTMF) and supported by the M3 Group ecosystem of over 330,000 Japanese and 6.5 million global physician members.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Research Associate (CRA) / Monitoring Services Clinical trial monitoring services covering Phase I through IV trials, including feasibility studies, site selection, source data verification (SDV), and regulatory compliance verification for pharmaceutical, biotech, and medical device sponsors.
• Data Management Services EDC design and implementation, data cleaning, query management, CDISC-compliant data conversion (SDTM/ADaM), and database management for clinical trials.
• Biostatistics / Statistical Analysis Statistical analysis planning, SAS programming, dataset creation, and statistical report preparation for clinical development.
• Pharmacovigilance Services Safety information collection, evaluation, regulatory reporting (PMDA), periodic safety update reports, and adverse event management for clinical trials and post-marketing surveillance.
• Medical Writing Services Clinical document preparation including protocols, informed consent forms, clinical study reports, CTD modules, and regulatory submission support.
• Regulatory Affairs Consulting Regulatory strategy development, PMDA consultation support, approval application preparation, and compliance guidance for pharmaceutical and medical device products.
• RBQM Solution (Risk-Based Quality Management) Risk-Based Quality Management services including Critical-to-Quality (CtQ) factor identification, cross-functional risk management planning, QTL/KRI monitoring, and integrated Quality Risk Management Plan (IQRMP) aligned with ICH-E6(R3).
• Regenerative Medicine Development Support Comprehensive services for regenerative medicine product development including regulatory strategy, GCP compliance framework, monitoring, data management, and PMDA consultation support.
• MPI Digital Trial Services Proprietary digital platform providing EDC, ePRO, eConsent, and eTMF solutions for clinical trial data management and patient engagement, integrated with M3 Group's physician network.
• Global Pharmaceutical Development Center (GPDC) Dedicated service unit supporting emerging biopharma companies in bringing innovative products to Japan, including IND/NDA/ODD preparation, PMDA consultations, and clinical development package planning.
• Medical Imaging Analysis (Imaging CRO) Central image reading and evaluation services supporting multiple imaging modalities (X-ray, CT, MRI, PET, SPECT, ultrasound, endoscopy) with AI qualification testing capabilities and DICOM data blinding.
• Software as a Medical Device (SaMD) Development Support Regulatory consulting, PMDA consultation, clinical trial notification (jRCT), AI diagnostic device imaging work, and statistical analysis for program medical devices (SaMD).
• Medical Device Development Services Full-service medical device development support including regulatory submissions, GCP compliance, data management, and post-marketing surveillance.
• CDISC Services CDASH-compliant CRF design, SDTM and ADaM data conversion, define.xml creation, and regulatory submission readiness for international standards.
• Clinical Pharmacology / Phase I Services Early-phase clinical trial services including BE (bioequivalence) trials, clinical pharmacology unit selection, and Phase I study execution.
• Quality Assurance / GCP Audit GCP audit services for contracted clinical trials, medical institution audits, and system audits to ensure regulatory compliance.
• Global/International Joint Clinical Trials Multinational clinical trial management including project management, monitoring, medical monitoring, and document translation services.
• AI and Digital Health Services AI tool-enabled clinical trial network building, AI diagnostic device imaging services, ePRO/eConsent solutions, and digital transformation support for clinical trials.
• CPOC (C-POC) Monitoring Services Subsidiary company providing specialized monitoring services including both blinded and unblinded CRA support, with comprehensive quality control and training programs.
• Privacy and Information Security Services Personal information protection management, data security measures, and compliance with Japanese and international privacy regulations including GDPR and CCPA frameworks.

Quantifiable outcome

• Global studies account for approximately 60% of total studies
• +1 more outcomes

Named customers3 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

AI capability3 records

Feature5 records

Partnerships

Six partnerships are on record, tiered core, key and supporting.

• M3 Inc. (株式会社エムスリー)coreStrategic or Co-development PartnerParent company listed on Nikkei 225 Index. Provides physician platform (m3.com with 330,000+ Japanese and 6,500,000+ global physician members), medical IT services, and group synergies for clinical trial optimization. MPI is a core subsidiary with the largest employee base among 100+ group companies.
• 3H / Qlife (患者データベース)coreTechnology or IntegrationJapan's largest patient database utilized for subject recruitment in clinical trials. Integrated with MPI's CRO services to accelerate patient enrollment.
• Oncolo / Rares / Gan Plus / 治験君keyTechnology or IntegrationPatient recruitment platforms (Oncolo for oncology, Rares for rare diseases, Gan Plus, Chiken-kun) integrated with MPI services for targeted subject recruitment.
• EdanzsupportingStrategic or Co-development PartnerProvides registry utilization services for pharmaceutical approval applications, collaborating with MPI on evidence-based regulatory submissions.
• TransCelerate BioPharma Inc.supportingTechnology or IntegrationRACT (Risk Assessment and Categorization Tool) developed by TransCelerate is used in MPI's RBQM solution services for standardized risk assessment in clinical trials.
• CPOC Co., Ltd. (株式会社シーポック)coreStrategic or Co-development Partner100% owned subsidiary specializing in monitoring (CRA) services and quality control. Established January 15, 2007 with 37,000 thousand yen capital. Provides both blinded and unblinded CRA services with comprehensive training programs.

Scale indicators5 records

Recent moves1 record

Expansion highlights6 records

Broad incumbents

• Medpace Holdings: Mid-to-large global CRO focused on Phase I-IV clinical development for emerging biopharma. Comparable to MPI's EBP-targeted GPDC offering but with global geographic reach and broader therapeutic-area coverage.
• Parexel International: Large global CRO with deep Japan-Asia presence and full-service clinical development capabilities. Competes directly with MPI for global pharma trials involving Japan sites and for Japanese biotech's international development work.
• ICON plc: Global full-service CRO offering clinical research, consulting, and laboratory services. Competes with MPI for multinational pharma trials and overlaps on data management, biostatistics, and regulatory affairs services.
• Syneos Health: Global biopharmaceutical solutions provider combining CRO and commercial services. Comparable to MPI on clinical execution and overlaps on regulatory/medical affairs, though much larger and now private.
• IQVIA Holdings: Global CRO and real-world evidence leader with extensive Japan operations. Overlaps with MPI on clinical trial execution and RWE services, but operates at vastly greater scale with a global site network and broader technology portfolio.
• Labcorp Drug Development (Fortrea): Global CRO spun out from Labcorp, offering clinical development and central laboratory services. Overlaps with MPI on Phase I-IV monitoring, data management, and central lab/imaging services.

Direct peers

• EPS Holdings: Japan's largest domestic CRO providing clinical trial support, data management, and SMO services to pharma and medical device companies. EPS is MPI's closest direct competitor for Japan-domestic clinical development mandates.
• CMIC Holdings: Japan-founded full-service CRO and CDMO with strong PMDA consultation expertise, offering clinical development, manufacturing, and post-marketing services. Competes head-to-head with MPI for Japanese pharma outsourcing contracts.

Regional players

• InCROM Inc. Japanese CRO offering Phase I-IV clinical trial services, SMO operations, and data management. Competes with MPI primarily within Japan for domestic pharma contracts and bioequivalence studies.

Emerging players

• Worldwide Clinical Trials: Mid-sized global CRO specializing in complex therapeutic areas and emerging biopharma support. Comparable to MPI's EBP-focused GPDC unit and niche therapeutic expertise but with broader geographic reach.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/mediscience-planning-inc-2182-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 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 Mediscience Planning