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 guidelines, Kun Tuo’s clinical safety management service covers the full-process pharmacovigilance system from protocol design to post-marketing surveillance, as well as the collection, assessment and report submission of adverse events (AE/SAE) and the establishment safety management Strategy. Relying on IQVIA’s global safety database and intelligent monitoring system, we realize efficient analysis and timely Asessment of cross-regional safety information. This ensures the protection of subject safety and sponsor rights, as well as meeting the regulatory requirements, building up a shield through scientific and rigorous safety management.
