Clinical trials safety monitoring and reporting is vital to ensure participant safety, data integrity and regulatory compliance.
Regulatory guidelines around clinical trial safety monitoring and reporting demand strict safety management procedures, from a highly-skilled, and experienced safety team.
Avance Clinical’s state-of-the-art built-for-purpose technology facilitates the management, reporting, and analysis of key safety information that may arise during study conduct.
Our safety monitoring and reporting services ensure regulatory compliance, and monitoring of the study drug safety profile to identify, evaluate and minimise safety-related risks at a reasonable cost.
Deep Regulatory Knowledge
As the leading Australian CRO for biotechs, Avance Clinical’s clients benefit from deep regulatory knowledge of the Australian and New Zealand clinical environment, a state-of-the-art safety and pharmacovigilance electronic database Argus, and a multi-disciplinary safety team with diverse therapeutic area expertise and decades of experience in safety management and reporting.