Service Capabilities

The PUCRI has in data management an internationally advanced system, a dedicated team with rich experience in international collaboration, a full set of standard operating procedure (SOP), authorized access to MedDRA and WHODrug, and a successful track record of high-quality clinical research projects.

1.    Electronic Data Management System
­    REDCap
REDCap (Research Electronic Data Capture) is a web application developed by Paul Harris’ group at Vanderbilt University. The PUCRI has installed REDCap on its proprietary server, which can be used for data capture, central randomization, online query management, e-signature, and data lock. Globally, the REDCap software and REDCap Cloud has been translated into 14 languages, running over 500,0000 clinical trials in 109 countries. It complies with the requirements of regulatory authorities in the US (21 CFR Part 11) and in China on electronic data capture, as well as the ALCOA principles of the ICH. (J Biomed Inform. 2009 Apr; 42(2): 377-81.)
­    Medidata
Medidata is a data management system developed by the US-based Medidata Solutions, and the PUCRI is the company’s strategic partner in China. Medidata Rave® is an industry-leading system used to capture, manage, and report clinical research data, operational data, and drug safety data of phase I-IV research projects. Medidata Rave integrates electronic data capture (EDC) and clinical data management (CDM) functions into a single platform, which improves clinical development and meets unique needs of each clinical trial. Medidata Balance, on the other hand, remotely manages central randomization and drug distribution. Globally, Medidata Rave and Medidata Cloud have been widely used, running over 14,000 clinical trials in 4 million patients. It complies with the requirements of regulatory authorities in the US (21 CFR Part 11) and in China on electronic data capture.
2.    Coding dictionaries
­    MedDRA, developed by the ICH and used for medical coding such adverse events
­    WHODrug, developed by the WHO for coding medicines in clinical research
3.    Data Management Software
­    SAS
­    EpiData
­    PLINK
4.    Data security and confidentiality
During the research process, strict confidentiality and safe file-saving measures were adopted for all documents of the project undertaken, and backup and safety procedures were used to protect the data stored in the computer system.