SAE Manager-Safety Data Communication & Management System for Clinical Trials
Comprehensive management of safety data, fully compliant with the latest GCP

New GCP——Significant changes underway for clinical safety data management
Sponsors as the principal responsible party for SAE/SUSARs in clinical trials,ethic Committees need to oversee, track and investigate safety reports with a full perspective
Investigators/institutions, as the responsible party for subject protection, need to keep timely track on SUSAR reports from sponsors

SAE management process under the new GCP
Ultra efficiency
in safety data management in clinical trials
System Features

Comprehensive informatization management

fully compliant with the latest GCP
One-key cross-site and cross-project distribution on SUSAR reports
Tracking and analysis on distribution/submission and receival status

Multi-party collaboration

Closed loop of pharmacovigilance in clinical trials
Center on sponsors while coordinating investigators, institutions and ethic committees, enabling communication and collaboration on clinical safety data

High-quality clinical data

From frontend input to backend analysis, breaking through the complete data chain
E2B template, input assistance and investigator training, ensuring data quality and integrity
Save data processing cost for sponsors and bring focus to analysis

Holistic subject protection

Enabling institutions and ethic committees to boost quality and efficiency in safety data processing
Opening up “God’s eye view” and bringing all safety reporting into control