The PUCRI has a strong team of biostatistics, which is led by figures prestigious in the field and guided by a full set of standard operating procedure (SOP). The team has a wealth of experience in statistical design and analysis for clinical trials of new drugs, innovative devices, and vaccines. It has also a successful track record in running independent data monitoring committees (DMCs).
It has authorized access to a full-fledged arsenal of software, including SAS 9.4, JMP Clinical, NCSS PASS 16.0, GraphPad Prism 5.0.4, and WinNonlin 8.1.
It has been involved in the design of more than 500 projects, covering a wide range of clinical fields and systems, including phase I-IV clinical trials of drugs and trials for the evaluation of medical devices.
The team has coauthored with clinical doctors a number of articles that appeared in high impact journals such as NEJM, The Lancet, and JACC.
The PUCRI team was the first in China that looked into DMC-related statistical methodology and took the lead in running DMCs for large-scale clinical trials. Such pioneering efforts has led to its rich experience from multiple major trials, an effective set of SOP, and a seasoned team for interim analysis. It sets the ground rules for how to set up and operate DMCs, and promotes such model, so as to move the entire industry toward a rule-based future.