info@zodiactrials.com
Full Service CRO in the Asia
Pharmacovigilance
1
Pharmacovigilance:
Comprehensive monitoring and management of drug safety throughout clinical trials. This includes the detection, assessment, and prevention of adverse events, ensuring compliance with regulatory requirements for patient safety.
2
Safety Management Plan Development:
Creation of tailored Safety Management Plans that outline protocols for handling adverse events, safety monitoring, data collection, and risk mitigation during clinical studies.
3
AE/SAE/SUSAR Management:
Efficient management and timely reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs), ensuring accurate documentation and causality assessments.
4
Safety Submissions to LECs and Authorities:
Preparation and submission of all safety-related reports to Local Ethics Committees (LECs) and regulatory authorities, ensuring timely communication and compliance with local and international regulations.