info@zodiactrials.com
Full Service CRO in Asia
Pharmacovigilance
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.
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.
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.
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.