About Kun Tuo
Kun Tuo is a full-service contract research organization (CRO) in China and a wholly owned subsidiary of Quintiles, the world’s largest provider of biopharmaceutical development and commercial outsourcing services. Our management team brings a wealth of experience from Quintiles and other leading multinational pharmaceutical Medical Device & Diagnostic (MDD) companies, with extensive operating and management experiences in China. We can leverage Quintiles best practices and combine with the local savvy to develop customized solution with superior quality.
Customer-oriented solutions for product development in China market
Based on your internal project requirements and budget, Kun Tuo provides integrated services and customized solutions that support the optimal allocation and use of your resources. Our offer covers the entire spectrum of clinical development, such as project management, clinical monitoring, data management, statistics and site management. In addition, we offer specialized services such as targeted regulatory interpretation; regulatory strategy consultation; medical support in specialist areas; key opinion leader (KOL) consulting; and medical statistics support during the formation of preliminary strategies for clinical research projects. These offerings can help you develop an optimal clinical research protocol and product development strategy for the Chinese market.
Therapeutic expertise and a broad Chinese footprint
Since its inception in 2012, Kun Tuo has provided a large number of international and domestic pharmaceutical with a full range of clinical research services in different therapeutic areas including oncology, psychiatric disorders, digestive and cardiovascular diseases, endocrinology disorders, and infections. Medical Device & Diagnostic (MDD) services cover therapeutic areas such as cardiovascular, osteology, endocrinology，hemodialysis and medical cosmetology etc.
Based in Beijing and Shanghai, Kun Tuo extends its services to other major cities such as Harbin, Changchun, Shenyang, Dalian, Shijiazhuang, Tianjin, Jinan, Qingdao, Zhengzhou, Hefei, Xi’an, Wuhan, Changsha, Nanjing, Suzhou, Hangzhou, Kunming, Nanning, Chengdu, Chongqing, Guangzhou, Fuzhou and Xiamen.
Medical Device & Diagnostic (MDD) expertise across the spectrum
Responding to the recent regulatory changes in China, Kun Tuo has launched a dedicated Medical Device & Diagnostic (MDD) & Diagnostic (MDD) unit in China. The MDD Unit in Kun tuo leverages Quintiles and Novella’s expertise – as well as support from and China-based device experts – to provide services in the areas of regulatory consulting, safety management, project management, clinical monitoring, data management, statistics, clinical evaluation report (CER) writing and medical writing.
Since the release of the new device regulation of CER in 2015, a dedicated CER unit has been established within Kuntuo and the service has been provided to some well-known device MNCs. Through high quality CER deliveries, we have supported clients to successfully get CFDA registration approval.
We also offer extensive experience in cardiovascular stents, peripheral stents, orthopedic, ophthalmology, oral, neurosurgery, trauma surgery, medical cosmetology diagnostic reagents and test equipment.
Sites and investigators: database resources and expertise
Kun Tuo offers a unique combination of global-quality services with local cost-effectiveness. Our medical experts maintain close and cooperative relationships with sites and key opinion leaders in many therapeutic areas – which helps us provide a wide range of medical support and expert consultancy at the strategy-setting and protocol-design stages, using optimal research strategy and planning efficiency.
We also have access to Quintiles’ sites and investigator database resources in China. The investigator database includes a grand pool of information on high-quality investigators and sites, supporting rapid site identification and study recruitment to speed study start-up and provide significant savings in time and resources.
A comprehensive SOP system, adapted for clinical research in China
Kun Tuo’s comprehensive standard operating procedure (SOP) system covers all service lines and is rooted from Quintiles’ SOP framework and guidelines. We prepare new SOP documents according to clinical research standards in China while adhering to Quintiles’ key work processes – and incorporate any adjustments in accordance with China’s legal requirements and Kun Tuo’s corporate structure.
KeySOP documents are reviewed and approved by Quintiles’ QA Department. Our SOP system, adapted for clinical research for both drug and Medical Device & Diagnostic (MDD) development in China, allows us to offer flexible, professional and comprehensive services to better support your research delivery in China.
Compliance with global information confidentiality and business ethics standards
Every Kun Tuo employee receives training on compliance with Quintiles’ global standards for information confidentiality, business ethics and anti-bribery codes. These training programs are compulsory and must be completed during the New Employee Orientation. Only employees who complete this training and pass an examination are authorized to work with our customers.
Experienced local managers and teams
Our seasoned management team members come from Quintiles, various multinational pharmaceutical/Medical Device & Diagnostic (MDD) companies and other well-known CROs. They have extensive operational experiences in clinical research. This allows our local team to provide comprehensive and professional services and to support our customers in improving their probability of success.
Robust and professional training system
Our training system is based on the Quintiles training platform and best practices, incorporated with local operational know-how, to make sure that our team is equipped with the expertise to execute your project quickly, efficiently and reliably. We look forward to collaborating with you.