Pharmacovigilance and Monitoring of Adverse Events in Full-Lifecycles, to Ensure the Clinical Study Safety Compliance and the Control of Risks
Based on ICH-GCP, E2A, E2B, E2D and other international regulations, Kun Tuo’s clinical safety management service provides pharmacovigilance system in the whole processes from protocol design to post-marketing surveillance, as well as the collection, assessment and report submission of adverse events (AE/SAE) and the establishment of risk control plan. Depending on IQVIA global safety database and intelligent early-warning system, we have achieved quick identification and compliant responses to cross-regional safety signals, so as to protect the subjects’ safety and sponsors’ rights, as well as meeting the regulatory requirements, building up a shield through scientific and rigorous safety management.
