WuXi Clinical
WuXi Clinical is a full-service global CRO providing Phase I-IV clinical development services (operations, biometrics, regulatory, pharmacovigilance) for pharmaceutical, biologics, medical device, and IVD sponsors across China, the US, Australia, and Taiwan, operating as a wholly-owned subsidiary of WuXi AppTec.
- Company typePrivate
- Founded2015
- HeadquartersAustin, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What WuXi Clinical does
WuXi Clinical (康德弘翼) is a full-service Contract Research Organization (CRO) providing Phase I to Phase IV clinical development services for pharmaceutical, biologics, medical device, and IVD developers. The company operates a one-stop-shop full-service model augmented by Functional Service Provider (FSP) and Strategic Solutions staffing models, with service modules spanning early clinical, clinical operations, biometrics (data management, programming, biostatistics), medical monitoring, regulatory affairs, quality management, medical and scientific writing, and pharmacovigilance. Headquartered in Shanghai with a US regional hub in Austin (acquired via the 2018 ResearchPoint Global merger) and a San Diego biometrics hub (acquired via the 2019 Pharmapace acquisition), the firm runs offices in 13 cities across China, the United States, Australia, and Taiwan and employs 850+ clinical research professionals.
The technology backbone combines the Medidata Rave ecosystem (CTMS, eTMF, EDC, RTSM) with a proprietary Clinical Integrated Data Platform that bundles AI medical coding, risk-based quality management (RBQM), ePRO/eCOA capture, standardized CRF library, statistical integration (SAAP), and data cleaning modules. Strategic hospital partnerships (Tianjin Cancer Hospital, Tongji East Hospital, Shanxi Bethune Hospital, Nanyang Medical College First Affiliated Hospital, Shanghai First People's Hospital) anchor site capacity, particularly in oncology and diabetes.
The company monetizes through professional services contracts with global pharma and biotech sponsors, including Haisco, Daiichi Sankyo, CStone Pharmaceuticals, BioMarin, EigerBio, Mabwell, Harbour BioMed, LegoChem, and Ocumension among others, earning project-based revenue tied to study scope, timelines, and resource intensity. It is a wholly-owned subsidiary of WuXi AppTec (603259.SH / 2359.HK), though a 2025 FierceBiotech report indicates WuXi AppTec is divesting its China-based clinical units to Hillhouse Investment, a transition that may materially alter ownership structure.
WuXi Clinical firmographics
Firmographics- Name
- WuXi Clinical
- Legal name
- 康德弘翼 (WuXi Clinical)
- Website
- https://wuxiclinical.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- WuXi Clinical is a full-service global CRO providing Phase I-IV clinical development services (operations, biometrics, regulatory, pharmacovigilance) for pharmaceutical, biologics, medical device, and IVD sponsors across China, the US, Australia, and Taiwan, operating as a wholly-owned subsidiary of WuXi AppTec.
- Ownership category
- akta.pro rank
WuXi Clinical industry classification
Industry- Product category
- Clinical Research Organization (CRO) Services
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)
- 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
- Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), KOL Engagement & Medical Education (Advisory Boards/CME Support) (HLAGALAM)
Keywords
Where WuXi Clinical is headquartered
LocationHeadquarters
- HQ city
- Austin
- HQ country
- United States
- HQ region
- North America
Offices14 records
Markets served
WuXi Clinical business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Clinical Research Services: Full-service CRO providing Phase I to Phase IV clinical research development services for pharmaceuticals, biologics, medical devices, and IVD devices, including project management, site selection, patient recruitment, clinical monitoring, data management, biostatistics, regulatory consulting, and pharmacovigilance services. Revenue generated through professional services contracts with pharmaceutical and biotech companies.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
WuXi Clinical product offering
Product offeringCore offering
WuXi Clinical is a global full-service Contract Research Organization (CRO) providing Phase I to Phase IV clinical development services for pharmaceutical, biologic, medical device, and IVD products. Services are delivered via three models — one-stop-shop full-service, Functional Service Provider (FSP), and Strategic Solutions — and include early clinical development, clinical operations, biometrics (data management, programming, biostatistics), medical monitoring, regulatory consulting, quality management, pharmacovigilance, and medical writing.
Product overview
WuXi Clinical is a full-service Contract Research Organization (CRO) providing comprehensive clinical development services for pharmaceuticals, biologics, medical devices, and IVD devices across Phase I to Phase IV clinical trials. The company operates a one-stop-shop full-service model supplemented by Functional Service Provider (FSP) and Strategic Solutions service delivery models. Core service modules include Early Clinical Services, Clinical Operations, Biometrics (Data Management, Programming, and Biostatistics), Medical Monitoring/PVG, Regulatory Affairs, Quality Management, Medical Affairs, Pharmacovigilance, and Medical & Scientific Writing. The company also offers proprietary technology platforms including a Clinical Integrated Data Platform with AI Medical Coding, standardized CRF library, SAAP statistical analysis platform, ePRO/eCOA platform, data cleaning platform, and RBQM (Risk-Based Quality Management) platform. WuXi Clinical leverages Medidata ecosystem (Rave CTMS, Rave eTMF, Rave EDC, Rave RTSM) for integrated clinical trial management.
Differentiator
Problem solved
Functional benefit
Products and services
- One-Stop-Shop Full-Service CRO (Phase I-IV Clinical Trials) End-to-end clinical development services covering trial design, study startup, implementation, data management, statistical analysis, regulatory submission, and approval for Phase I-IV trials of pharmaceuticals, biologics, medical devices, and IVD products.
- Functional Service Provider (FSP) Flexible staffing model providing dedicated resources managed by WuXi Clinical at their facilities using client-preferred systems and processes to reduce administrative burden on sponsors.
- Strategic Solutions Services Placement of experienced WuXi Clinical professionals at client offices to support specific tasks and address staffing fluctuations during clinical development.
- Early Clinical Services Phase I early clinical development services including first-in-human studies, clinical pharmacology research, and early proof-of-concept studies.
- Clinical Operations Full-service clinical trial management covering project management, site selection and startup, patient recruitment, site monitoring and management, and clinical trial self-inspection support.
- Biometrics Services (Data Management, Programming, and Biostatistics) Comprehensive clinical data services including data management, statistical programming, biostatistics consultation, CDISC submission standards, and clinical data integration delivered by a 200+ professional team.
- Medical Monitoring and Pharmacovigilance (Medical Monitoring/PVG) Drug safety services including PV system setup, clinical safety data management, post-marketing safety data management, PV database system service, signal detection and evaluation, DSUR/RMP/PSUR preparation, and medical monitoring.
- Regulatory Affairs Consulting Registration and regulatory consulting services covering the full lifecycle of pharmaceuticals, medical devices, diagnostics, and dietary supplements across China, US, Canada, and global markets.
- Quality System Management and Consulting Quality management system focused on risk control, data integrity, and patient protection, including compliance audits, procedural and regulatory compliance, and operational synergy across departments.
- Medical and Scientific Writing Medical writing services for protocols, clinical study reports, investigator brochures, regulatory submissions, publications, lab manuals, dosing instructions, informed consent forms, and research handbooks.
- Medidata Rave CTMS and eTMF System Implementation (Integrated Clinical Trial Management Platform) Integrated clinical trial management and electronic trial master file platform with 600+ configurable features and approximately 100 report types for project managers, enabling real-time data synchronization across project management, document management, and data management functions.
Companies that use WuXi Clinical
Customer profileNamed customers17 records
Segments4 records
Ideal customer profiles2 records
WuXi Clinical technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
AI capability3 records
Feature7 records
WuXi Clinical partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- Nanyang Medical College First Affiliated Hospital (南阳医专一附院)coreStrategic cooperation for drug clinical trial development. Hospital has successfully filed 15 drug clinical trial specialties and 20 medical device clinical trial specialties, undertaking 380+ projects, with strong performance in diabetes research.
- Shanghai First People's Hospital (上海市第一人民医院)coreWuXi Clinical participates in hospital's 'Clinical Research Open Day' program for collaboration on enterprise clinical trial needs, clinical trial efficiency improvement, and ADC drug clinical development.
- Tianjin Cancer Hospital (天津市肿瘤医院)coreStrategic cooperation center with Tianjin's leading cancer hospital for Phase I clinical trials and oncology drug development. Hospital serves as lead site for multiple WuXi Clinical projects including CD-001 and T320 ADC trials.
- Tongji University Affiliated East Hospital (同济大学附属东方医院)coreWuXi Clinical signed strategic cooperation agreement with East Hospital for multi-channel, multi-level, and multi-dimensional collaboration in drug clinical trial development, supporting accelerated clinical trial development and Shanghai's position as pharmaceutical innovation leader.
- Tianjin Free Trade Zone / National Supercomputing Center TianjinminorWuXi Clinical participated in China Tianjin Free Trade Zone medical ecosystem development forum and signed for high-quality real-world data platform co-construction.
- Shanxi Bethune Hospital (山西白求恩医院)coreStrategic partnership with Shanxi Bethune Hospital for clinical research collaboration. Hospital has conducted 100+ clinical studies and passed NMPA inspections with strong expertise in diabetes and other therapeutic areas.
- PharmapacecoreWuXi AppTec acquired Pharmapace to enhance biometrics capabilities in US and Europe. Pharmapace provides full range of biometrics services including clinical/statistical programming, data management, biostatistics, and medical writing. Integration enabled round-the-clock global biometrics services.
- MedidatacoreWuXi Clinical implemented Medidata Rave CTMS and Rave eTMF systems for integrated clinical trial management. The partnership began in 2016 with Medidata RAVE Partner certification, expanded in 2017 with Rave RTSM Partner certification, and integrated the full platform in 2019. WuXi Clinical has completed 100+ clinical studies on the Medidata platform.
Scale indicators10 records
Recent moves7 records
Expansion highlights6 records
WuXi Clinical competitors and assessment
Company assessmentMarket position
Strengths4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
WuXi Clinical social profiles
Digital presenceWuXi Clinical financial estimates
Financial estimateRevenue estimate
Valuation estimate
WuXi Clinical leadership team
Management profileNumber of profiles
Profiles3 records
WuXi Clinical subsidiaries and ownership
Company hierarchySubsidiaries2 records
WuXi Clinical funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
WuXi Clinical 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 WuXi Clinical
What does WuXi Clinical do?
WuXi Clinical is a global full-service Contract Research Organization (CRO) providing Phase I to Phase IV clinical development services for pharmaceutical, biologic, medical device, and IVD products. Services are delivered via three models — one-stop-shop full-service, Functional Service Provider (FSP), and Strategic Solutions — and include early clinical development, clinical operations, biometrics (data management, programming, biostatistics), medical monitoring, regulatory consulting, quality management, pharmacovigilance, and medical writing.
Is WuXi Clinical a public or private company?
WuXi Clinical is a private company. It is classified as corporate owned and is currently operating.
When was WuXi Clinical founded?
WuXi Clinical was founded in 2015. It employs 101 to 250 people.
Where is WuXi Clinical based?
WuXi Clinical is headquartered in Austin, United States, in the North America region.
How does WuXi Clinical make money?
One revenue line is on record: clinical Research Services.
Does WuXi Clinical have an API?
No public API is recorded for WuXi Clinical.
What industry is WuXi Clinical in?
WuXi Clinical's product category is Clinical Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAH, Pharmacovigilance, Risk Management & Medical Affairs CROs. Its NAICS code is 54171 and its SIC code is 8731.