GCP ClinPlus
GCP ClinPlus is a China-headquartered contract research organization founded in 2003 providing end-to-end clinical trial and biometrics services across therapeutic areas including oncology, cell and gene therapy, and rare diseases. It serves pharmaceutical and biotech sponsors globally through FSO, FSP, and consulting engagements anchored by CDISC platinum standards capabilities.
- Company typePrivate
- Founded2003
- HeadquartersHangzhou, China
- Headcount11–50
- GTM typeB2B
- OfferingServices
What GCP ClinPlus does
GCP ClinPlus is a privately held contract research organization founded in 2003 and headquartered in Hangzhou, China, with a US biometrics office in Cranbury, New Jersey. The company provides end-to-end clinical research services across eight integrated service areas: Medical Affairs, Clinical Research and Development, Registration Affairs, Field Service, Data Management/Biostatistics/Programming, Quality Assurance, Medical Research Joint Center, and Pharmacovigilance, covering Phases I through IV, bioequivalence/PK-PD studies, centralized and non-blind monitoring, and a dedicated Gene and Cell Therapy division for hematologic, solid tumor, and genetic disorder programs. Its technology foundation includes a CDISC-compliant Dynamic Data Integration Platform spanning raw data collection to regulatory-grade statistical analysis, a library of 110+ independently developed online tools, and 60+ independent intellectual property rights; the company is a CDISC platinum member with 12 years of experience supporting submissions to NMPA, FDA, and EMA.
The company reports 2,300+ completed projects, 210+ NDA approvals across NMPA, FDA, and EMA, a 67% project repurchase rate, and operations across 20 cities in China and the US. Its go-to-market is direct enterprise field sales targeting four buyer archetypes: Chinese innovators preparing assets for global out-licensing, Western companies seeking to in-license Chinese assets, international biotechs pursuing accelerated development through initial China studies, and multinationals building global-plus-China integrated strategies. Revenue is generated through professional services engagements structured as Full Service Outsourcing (FSO), Functional Service Provider (FSP) team extensions, strategic consulting, and biometrics services. Operating economics leverage the structural cost-speed arbitrage of China-based clinical research, with reported trial costs 60-80% below Western markets and patient recruitment 2-3 times faster than US/EU benchmarks, and recent 2025 milestones including NMPA approvals for Onradivir Tablets, Yipeisheng, a first-line nasopharyngeal carcinoma regimen, and China's first stem cell therapy for aGVHD demonstrate current pipeline activity.
GCP ClinPlus firmographics
Firmographics- Name
- GCP ClinPlus
- Legal name
- GCP ClinPlus
- Website
- https://en.gcp-clinplus.com
- Company type
- Private
- Founded year
- 2003
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- GCP ClinPlus is a China-headquartered contract research organization founded in 2003 providing end-to-end clinical trial and biometrics services across therapeutic areas including oncology, cell and gene therapy, and rare diseases. It serves pharmaceutical and biotech sponsors globally through FSO, FSP, and consulting engagements anchored by CDISC platinum standards capabilities.
- Ownership category
- akta.pro rank
GCP ClinPlus industry classification
Industry- Product category
- Contract Research Organization (CRO) Services
- NAICS
- Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industries
- Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)
Keywords
Where GCP ClinPlus is headquartered
LocationHeadquarters
- HQ city
- Hangzhou
- HQ country
- China
- HQ region
- Asia
Offices3 records
Markets served
GCP ClinPlus business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D
Revenue model
- Full Service Outsourcing (FSO): End-to-end clinical research services covering the entire drug development lifecycle from preclinical consultation through clinical trial execution and regulatory submission support
- Functional Service Provider (FSP): Dedicated team extensions providing flexible resourcing for specific clinical operations functions, allowing sponsors to scale resources based on project demands
- Strategic Consulting: Expert advice at critical junctures including protocol design, regulatory strategy, and biometrics planning for clinical development programs
- Biometrics Services: Comprehensive data management, biostatistics, and SAS programming services supporting regulatory submissions
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
GCP ClinPlus product offering
Product offeringCore offering
GCP ClinPlus is a specialized Contract Research Organization (CRO) providing preclinical consultation and clinical services primarily in China with global reach. It delivers end-to-end clinical development solutions spanning medical affairs, clinical trial operations, regulatory affairs, biometrics (data management, biostatistics, SAS programming), quality assurance, pharmacovigilance, and field service, with specialized capabilities in cell and gene therapy. The company supports Phase I through Phase IV/non-interventional studies and has facilitated 160–210+ NDA approvals across NMPA, FDA, and EMA.
Product overview
GCP ClinPlus is a specialized CRO (Contract Research Organization) providing preclinical consultation and clinical services primarily in China with global reach. The company operates as a unified service platform offering end-to-end clinical development solutions organized into eight core service areas: Medical Affairs, Clinical Research & Development, Registration Affairs, Field Service, Data Management/Biostatistics & Programming, Quality Assurance Service, Medical Research Joint Center, and Pharmacovigilance. The service portfolio spans the full clinical trial lifecycle from Phase I through Phase IV/NIS, with specialized capabilities in bioequivalence/PK/PD studies, centralized monitoring, and non-blind monitoring. The company's Gene and Cell Therapy Division provides specialized CGT clinical development support. Biometrics services including data management, biostatistics, and SAS programming form an integrated offering with CDISC expertise for global regulatory submissions. The company supports development across multiple therapeutic areas including oncology, cardiovascular, cell & gene therapy, ophthalmology, endocrinology, neurology, respiratory, infectious disease, and immunology.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Affairs
Quantifiable outcome
- 67% project repurchase rate demonstrating high customer satisfaction
- +7 more outcomes
Companies that use GCP ClinPlus
Customer profileNamed customers7 records
Segments5 records
Ideal customer profiles4 records
GCP ClinPlus technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
GCP ClinPlus partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Former FDA Statistical Review ExpertscoreProvides guidance and support leveraging extensive FDA regulatory experience for navigating US regulatory requirements and submission strategies
- Five Leading Universities (Statistical Experts)core20 years of close collaboration with top statistical experts from five leading universities providing academic-industry bridge and innovative statistical methodologies
- Top-Tier Hospitals and Research InstitutescoreEngagement of industry-leading clinical specialists and statistical experts from elite institutions for expert technical support in clinical trials
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
GCP ClinPlus competitors and assessment
Company assessmentMarket position
Weaknesses4 records
Competitive moat5 records
Key risks4 records
Key highlights6 records
Customer concentration
GCP ClinPlus social profiles
Digital presenceGCP ClinPlus financial estimates
Financial estimateRevenue estimate
Valuation estimate
GCP ClinPlus leadership team
Management profileNumber of profiles
Profiles1 record
GCP ClinPlus funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
GCP ClinPlus M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about GCP ClinPlus
What does GCP ClinPlus do?
GCP ClinPlus is a specialized Contract Research Organization (CRO) providing preclinical consultation and clinical services primarily in China with global reach. It delivers end-to-end clinical development solutions spanning medical affairs, clinical trial operations, regulatory affairs, biometrics (data management, biostatistics, SAS programming), quality assurance, pharmacovigilance, and field service, with specialized capabilities in cell and gene therapy. The company supports Phase I through Phase IV/non-interventional studies and has facilitated 160–210+ NDA approvals across NMPA, FDA, and EMA.
Is GCP ClinPlus a public or private company?
GCP ClinPlus is a private company. It is classified as venture growth investor backed and is currently operating.
When was GCP ClinPlus founded?
GCP ClinPlus was founded in 2003. It employs 11 to 50 people.
Where is GCP ClinPlus based?
GCP ClinPlus is headquartered in Hangzhou, China, in the Asia region.
How does GCP ClinPlus make money?
Four revenue lines are on record. Full Service Outsourcing (FSO) is the primary driver. The others are functional Service Provider (FSP), strategic Consulting and biometrics Services.
Does GCP ClinPlus have an API?
No public API is recorded for GCP ClinPlus.
What industry is GCP ClinPlus in?
GCP ClinPlus's product category is Contract Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAL, Specialty Therapeutic-Area CROs (e.g., oncology/rare disease). Its NAICS code is 5417 and its SIC code is 8731.