关键词: Ⅰ期临床试验, 电子信息化, 伊柯夫BEIS系统

Abstract:

Since the China Food and Drug Administration (CFDA) released the "Announcement on Conducting Self-examination and Verification of Drug Clinical Trials" on July 22, 2015, the integrity and authenticity of clinical trial data has increasingly aroused the attention of sponsors, clinical drug trial institution, and contract research organizations (CROs). In order to further improve the standardization management, quality and efficiency of Phase I clinical trials and ensure the accuracy and reliability of various clinical data, our institute brought in the management system (BEIS) of Hangzhou ECRFPlus Technology Company Ltd. for clinical trials in 2017. Comparative analysis of clinical trials completed with or without using BEIS system showed that adoption of Electronic Management System resulted in many unsurpassed advantages such as less mistakes, fewer queries, lower study cost, and compressed study timeline. Moreover, when BEIS system docking to the third party system such as hospital information management system (HIS), laboratory information management system (LIS) and ECG network information system, it allows for the real-time digitalized information management of the whole process of clinical trials and integration of data capturing, data cleaning, trial management and even data mining in one system, which greatly improved the efficiency and quality of clinical study.

Key words: phase I clinical trials, electronic information, BEIS system