Established in June 18, 2008, Peking University Clinical Research Institute (PUCRI) is China’s first university-affiliated academic institution devoted to clinical research-related education, research, services, training, organizational coordination, technical support, and policy development. It is home to the Center of Excellence for Regulatory Sciences under the Peking University APEC Health Science Academy. It is committed to advancing clinical research in China and safeguarding human health through technical support and personnel training.

The PUCRI has four subordinate departments (Department for Education and Training, Department for Project Development and Management, Department for Data Management, and Department for Biostatistics), one center (Center for Real-world Evidence Evaluation), and a general office. It boasts a research team of a strong international view and outstanding academic capabilities, with 37 full-time faculty members (including 4 professors/fellows, 1 foreign expert, and 4 associate professors/associate fellows), 11 adjunct professors, 17 visiting professors, and 1 honorary professor. It publishes more than 50 papers annually, with an average IF over 5.0.

Since day one, the PUCRI has committed itself to building a training system for senior clinical research professionals in China. Its years of unremitting efforts has led to an evolving prototype, with 3 tiers (academic degree-oriented, vocational certificate-oriented, and workshop/seminar-based trainings) and 6 directions (ethical practices, project development and design, data technology and application, statistical design and analysis, project management and quality control, and regulatory sciences in clinical research). In 2012, the PUCRI-sponsored Chinese Course on Drug Development and Regulatory Sciences (CCDRS) was accredited by PharmaTrain and Hibernia College. This internationally acclaimed course has launched over a hundred training sessions, reaching more than 10,000 people. In 2013, the PUCRI received mandate from the Ministry of Education in setting up the secondary discipline of Sciences in Clinical Research, and started its master’s and doctoral programs. The programs have currently enrolled 15 graduates, and created 13 courses with a total of over 1,000 sign-ups. In 2018, one of the courses, “Scientific Methodology in Clinical Research”, was recognized by the National Steering Committee for Academic Graduate Programs in Medicine as a core course for clinical medicine.

The PUCRI has an internationally-aligned platform to support clinical research, complete with a standard operating procedure (SOP), the world’s top database management system (including Medidata, Viedoc, and Redcap), and China’s best computer network platform. With an internationally accredited data management team, the PUCRI is competent for world-class research projects. In 2011, the PUCRI set up the Beijing Technical Service Center for Design and Management of Clinical Trials of New Drugs. It is capable of designing, executing, supervising, and coordinating quality clinical research projects and providing such services beyond the campus, and has so far provided technical support to over 100 government-sponsored projects (Beijing Municipal Science and Technology Commission, the Chinese Ministry of Science and Technology, as well as government agencies of the US, UK, and Australia) and over 700 business/institution-sponsored projects. In 2019, the PUCRI joined strengths with the Vascular Center of Peking University Shougang Hospital in creating the Research Center for Heart and Vascular Health, marking a new model for cooperation between research institutes and university-affiliated hospitals.

As an active contributor to the establishment in 2010 of the Human Research Protection Program (HRPP) at the PKU, the PUCRI has since functioned as its quality assurance office and ethics training office. This effort gave the final piece to a sound management system for clinical research at the PKU (featuring administration by the PKU Department of Research, academic supervision by the HRPP and the IRB, and technical support and training by the PUCRI), representing a departure from a chaotic past where academic projects had been carried out without proper supervision, transparency, and quality control. The success paved the way for grants from the NIH and other international agencies to the PKU, saw the establishment of a number of joint institutes/centers for clinical research between the PKU and international partners, and advanced clinical research and translational medicine in affiliated hospitals. In 2018, the PUCRI was recognized by the Municipal Health Commissions of Beijing and Shenzhen as Quality Improvement Center for Clinical Researches. In Beijing in particular, the PUCRI provided key technical support for the establishment of a three-tiered quality control system as part of a Capital Health Research and Development Project. It is also the technical lead for the PKU National Joint Research Center for Translational Medicine and Clinical Research commissioned by the Ministry of Education and Ministry of Science and Technology in 2019.

In 2016, the PUCRI launched its Shenzhen branch. Supported by the Sanming Project of the municipal government, the PUCRI (Shenzhen), also known as Clinical Research Institute of Shenzhen PKU-HKUST Medical Center, began to contribute its technical edge to local clinical research through training as well as platform and supervision system building.

Going forward, the PUCRI will keep perfecting the clinical research system and the training system at the PKU, and build itself into an academic body of widespread influence, an incubator of top-notch talents, a demonstration site for clinical trials, and a thinktank for regulatory policies.