Description
Kun Tuo was established in May 2012 as the CRO entity set up in the Chinese market by IQVIA (then Quintiles), dedicated to providing high-quality and cost-effective services for drug and Medical Device & Diagnostic (MDD) research and development in China.
The company is a wholly owned subsidiary of IQVIA, the world’s largest provider of biopharmaceutical development and commercial outsourcing services. Its management team draws on experience from IQVIA and other leading multinational pharmaceutical and MDD companies, combining global operating standards with local market knowledge to deliver customised solutions.
Kun Tuo’s primary client base spans both domestic Chinese pharmaceutical companies and international sponsors seeking a locally embedded partner for China-market clinical development. The company operates across a wide range of therapeutic areas including oncology, psychiatric disorders, digestive and cardiovascular diseases, endocrinology, and infectious diseases. Its MDD services cover cardiovascular, osteology, endocrinology, haemodialysis, and medical cosmetology.
Kun Tuo maintains offices in Beijing and Shanghai, with additional locations in Guangzhou, Chengdu, and Hangzhou. The company’s field reach extends to more than 20 major cities across China, including Harbin, Tianjin, Wuhan, Nanjing, Chongqing, and Xiamen, among others.
Key Products and Services
Clinical Research Services (Pharmaceutical)
- Clinical trial monitoring and site management
- Project management across all clinical phases
- Medical affairs support
- Biological statistics and biostatistics
- Data management and electronic data capture
- Regulatory affairs and submissions to the National Medical Products Administration (NMPA)
- Pharmacovigilance and drug safety management
- Medical writing and translation services
Medical Device & Diagnostic (MDD) Services
- Regulatory consulting, safety management, project management, clinical monitoring, data management, statistics, Clinical Evaluation Report (CER) writing, and medical writing for medical device sponsors
- A dedicated CER unit established following the release of China’s updated device CER regulation in 2015, supporting clients in obtaining NMPA (formerly CFDA) registration approval
- Expertise across cardiovascular stents, peripheral stents, orthopaedic devices, ophthalmology, oral, neurosurgery, trauma surgery, medical cosmetology, diagnostic reagents, and test equipment
- A dedicated MDD unit launched in response to regulatory reforms in China
Quality and Compliance
- Key SOP documents reviewed and approved by IQVIA’s Quality Assurance department, adapted for both drug and MDD clinical research in China
- Mandatory compliance training for all staff covering IQVIA’s global standards for information confidentiality, business ethics, and anti-bribery codes
Kun Tuo occupies a distinctive position as an IQVIA-owned, China-dedicated CRO — a structure that enables it to offer sponsors the operational and quality standards of a global organisation whilst maintaining the regulatory familiarity, site relationships, and local cost structure of a domestic provider. The company’s ability to leverage IQVIA best practices alongside local expertise allows it to develop customised solutions with a combination of global quality and local cost-effectiveness — a proposition particularly relevant to multinational sponsors navigating China’s evolving regulatory environment and to domestic companies seeking internationally aligned development standards. Its breadth of city-level coverage across China positions it as a capable partner for large-scale, multi-centre clinical programmes within the market.
Capabilities
Contact Information
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