Shulan Hangzhou Hospital clinical trial institution (hereinafter referred to as "the institution") was formally established in May 2017,passed the national drug clinical trial institution (GCP) qualification in July 2018, obtained the NMPA medical device clinical trial institution record number in November 2018 and completed the national stem cell clinical research institution record in September 2019. In November 2020, we completed the filing of special food verification and evaluation technology institutions. So far, twenty professional filings for drug clinical trials and twenty-four professional filings for medical device clinical trials have been completed.Besides, the phase I clinical trial research center covers an area of 1,500 square meters, with 60 beds and 2 rescue beds, and independent functional areas, including screening area, activity area, secret collection area, rescue room and laboratory. An independent GCP central pharmacy, a central archive room and an independent quality assurance system have been built to guarantee the efficient development and high-quality operation of clinical trials.

The clinical trial institution has one institution director, who is an academician of the Chinese Academy of Engineering, and three institution deputy directors. The staff team of the institution is 17 in total, with 9 intermediate titles or above, including 1 CDE review expert from State Drug Administration and 4 GCP verification experts.