Avance Clinical offers Argus-backed safety reporting services.
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 ensures regulatory compliance, and monitoring of the study drug safety profile to identify, evaluate and minimise safety-related risks at a reasonable cost.
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.
High-quality in-house CRO services offered by the Avance
Clinical Safety and Pharmacovigilance team:
- Study-specific training for Investigational Sites on Safety Reporting
- Argus Sponsor enterprise set-up and Study-Specific Safety Database set up
- Preparation of the Study Specific Safety Reporting Plan, Safety Reporting Forms and relevant guidelines for the Investigational Sites
Receipt and processing of Individual Case Safety Reports in Argus which include:
- Data entry, Medical Coding (MedDRA and WHODD), QC, Medical Review and Distribution
- Follow-up and query management
- Expedited reporting of SUSARs and other safety information such as Significant Safety Issues and Urgent Safety Measures to relevant stakeholders such as Regulatory Authorities, ECs and Investigators
- Periodic Safety reporting to local ECs and Investigators
- DSUR distribution and submission to Investigations and ECs
- Preparation and submission of Annual Safety Reports in Australia