Avance Clinical offers complete study specific safety reporting services.
Safety monitoring and reporting in clinical research trials is integral to the conduct of clinical research to ensure both patient safety, data integrity and regulatory compliance. Strict regulatory guidelines on clinical trial safety monitoring and reporting necessitate the preparation and implementation of study specific safety monitoring and reporting strategies and procedures. Our safety monitoring and reporting services help you ensure regulatory compliance, with optimal efficiency at a reasonable cost.
As a leading Australian CRO, our clients benefit from our regional regulatory knowledge, quality systems approach, multi-disciplinary safety expertise and adherence to reporting timelines of the Australian Therapeutic Goods Administration (TGA) and other competent authorities.
Avance Clinical offers complete study specific safety reporting services, which include data collection, processing, review, safety report writing and reporting. Our dedicated safety monitoring and reporting team comprises highly skilled individuals with in-depth knowledge in diverse therapeutic areas and several years of clinical trial safety management services experience.
High-quality in-house CRO services offered by the Avance safety reporting and monitoring team:
- Safety Management
- Reporting Plans/ Forms
- SAE/Pregnancy Report Receipt and Processing
- SAE Narratives
- Reporting to Local Regulatory Authorities and Ethics Committees
- Expedited/Periodic Safety Report Distribution
- Training of trial investigators and site study staff on study specific monitoring and reporting
- Dedicated service with 24/7 phone and fax lines to receive information on adverse events from clinical trial sites
- Collection, evaluation, analysis and reporting of safety information
- Coding of Adverse Events (MedDRA)
- Review of case reports
- Preparation and submission of Safety Update Reports to the TGA and other competent authorities
- Preparation and submission of expedited reports to the TGA and other competent authorities