eSafety | Pharmacovigilance System
Comprehensive Integration of Drug Safety Work Flow to Improve Efficiency and Quality
eSafety is a professional information system in the pharmacovigilance field jointly built by senior drug safety management experts with working experience in domestic and foreign pharmaceutical companies, and leading computer engineers after we have a profound insight into the drug safety area.
eSafety creates product safety information database and integrates clinical research and post-market product safety data to build big database. It can improve the efficiency of report processing by 50% while standardizing the report processing flow.
eSafety 3-End Integrated Information Collection Approach
PC: for literature reporting and feedback information collection
Mobile APP: for spontaneous report and follow-up information collection
IPAD APP: for the collection of AE information for clinical trials
eSafety System Design in Line With International Standards and China's National Conditions
Title 21 CFR: System Basic Standard
ICH E2B:Data Interchange Standard
GAMP5: System Validation Standard
Compliant processing of reports from various sources
Informatized processing of national feedback data
Automatic write-up of adverse events description
PSUR report online write-up and submission to management