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General Information

About Us
Peking University Clinical Research Institute (PUCRI) was established in June 18, 2008, as an affiliation of the Peking University Health Science Center (PUHSC). It is China’s first academic institution devoted to education & training, research, services, management & coordination, technological support, and policy development in clinical research.

Our mission
The PUCRI is committed to improving human health through advancing clinical research, by producing talents in clinical research and providing technological support that enables quality clinical research.

Our work

Building an enabling environment of win-win cooperation that matches the demands of the nation and society
High quality clinical research is a cornerstone to the development of clinical disciplines, the R&D at pharmaceutical companies, and the national strategy of innovation. Development in this field therefore calls for synergy of the academia, industry and government. To this end, the PUCRI has launched cooperation with domestic and international partners and mobilized resources both within and beyond the campus. As a result, an academic exchange platform has been built, where such synergy becomes possible. At the same time, an “institute-university-beyond” three-tiered working team has been developed to execute our mission and benefit our partners.

Building a world-class platform of technological support for clinical research
The PUCRI makes it the top priority to build a strong platform to meet the requirement of large-scale clinical research. It endeavors to recruit highly competent people into its multidisciplinary team, bring in advanced technologies, and standardize its operations. The PUCRI currently has four research departments including  Project Development and Management, Education and Training, Data Management, and Biostatistics plus one administrative office, and together they make a full-fledged team, a team guided by standard operating procedures and equipped with the world’s top database management system for clinical research. It is now capable of designing, executing, supervising and coordinating quality clinical research projects and providing such services beyond the PUHSC campus.
  • ■In 2009, the PUCRI partnered with Medidata Solutions and established the PUCRI-Medidata Clinical Research Technology Center, which gives the PUCRI access to Medidata Rave (a world's leading data management system) and Medidata Balance (a randomization module). With an internationally accredited data management team, the PUCRI is competent for top research projects both at home and abroad.
  • ■In 2011, the PUCRI set up the Beijing Technical Service Center for Design and Management of New Drugs Clinical Trials. The center has so far provided technical support to dozens of major projects sponsored by Beijing Municipal Science and Technology Commission, Ministry of Science and Technology, and international partnerships of Peking University (PKU).
  • ■In 2016, with support from the Shenzhen Municipal Commission of Development and Reform, Commission of Health and Family Planning, Commission of Science and Innovation, Food and Drug Administration and Administration of Hospitals, the PUCRI (Shenzhen) was inaugurated, giving a further push to the development of clinical research in China.
  • ■In 2017, with support from China Food and Drug Administration, the institute was approved formally as the Asia-Pacific Economy Commission (APEC) Regulatory Sciences Center of Excellence. The COE is expected to play a significant role in capacity building of China’s regulatory system, international cooperation, academic research and policy development.
  • Building a training system in line with international best practices
Innovation and development in clinical research requires a large number of highly talented people with strengths in both research and clinical medical practice. Therefore since day one of the PUCRI, it has made it its goal to produce such people and disseminate the latest theories, technologies and methods in the field. It has launched effective training programs on research design, protocol writing, code of ethics, quality assurance, electronic data capture, biostatistics, and drug development and regulatory sciences. At the PUCRI, a world-class training system of clinical research is taking shape.
  • ■The Chinese Course on Drug Development and Regulatory Sciences (CCDRS) started in 2009 and was accredited in 2012 by PharmaTrain and Hibernia College. It has been well recognized by pharmaceutical industries at home and abroad and now serves as a bridge among the government, industry and academia.
  • ■The International Training Camp on Clinical Research Design and Protocol Writing started in 2012 and has since provided trainings for PKU affiliated hospitals, the Beijing Municipal Administration of Hospitals, the Shenzhen Municipal Commission of Health and Family Planning, the Jiangsu Province People Hospital, and the Third Military Medical University. These trainings have been very well received among the trainees.
  • ■In November 2013, the Academic Degrees Committee of the State Council approved the master’s and doctoral programs of Sciences in Clinical Research. The first batch of candidates were enrolled in 2015.
Facilitating international collaborations on clinical research
Collaboration with top clinical research institutions around the world is an important part of the PUCRI’s development strategy. So far the PUCRI has established close ties with a number of prestigious partners, including the Duke Clinical Research Institute, the University of Michigan Health System, the Erasmus University Medical Center, the George Institute for Global Health, the University of Melbourne, the Imperial College London, the King's College London, the University of Manchester, the Ulm University, the McGill University and so on. These partnerships also bring in opportunities of cooperation in clinical research for the PUHSC as a whole.

Enabling a sound university-wide system for clinical research that departures from the lack of transparency, supervision and quality assurance
To match with international best practices, the PUCRI has been an active advocate for the establishment of the Clinical Research Program and the Human Research Protection Program at the PKU. Such efforts have paved the way for a clinical research (supporting) system that is in line with international standards, complete with expertise, special platform, special budget and special policies. In addition, the PUCRI has set up a special body to offer ethics trainings to all the clinical research projects initiated by PKU, conduct on-site inspections, and give feedback to the Institutional Review Board. In this way, the triple lack of supervision, transparency and quality assurance has been addressed, and risks under proper management.
  • ■On June 18, 2015, the Peking University Human Research Protection Program (PUHRPP) successfully passed the accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The PUCRI plays an important part in the PUHRPP where the PUCRI Department for Project Development and Management serves as PUHRPP’s quality assurance office and the PUCRI Department for Education and Training is PUHRPP’s training center.
  • Emergence of a number of high-caliber innovative projects in clinical research

Currently, more than 60 world-class large-scale clinical research projects are completed or undergoing on the platform of the PUCRI, and the sponsors include the US National Institutes of Health (NIH), the Australian National Health and Medical Research Council (NHMRC), the British Medical Research Council (MRC), the Chinese Ministry of Science and Technology, the Beijing Municipal Science and Technology Commission, the PKU Clinical Research Program, and the UMHS-PUHSC Joint Institute for Translational and Clinical Research. Some of the results have already been published on journals such as BMJ, Circulation, JACC, and JASN.

Going forward, the PUCRI will keep perfecting the clinical research system and the training system. It is our vision that the PUCRI will become the best clinical research institute in China, a leading one in Asia, and a renowned one in the world within 10 to 15 years. It will serve as a center for education & training, research, services, training, management & coordination, technological support, and policy development in clinical research.