George Clinical’s Safety and Pharmacovigilance experts ensure that a patient’s safety is paramount. Critical to the success of any clinical trial is the early identification and management of adverse events.
George Clinical has a dedicated safety group employed at all stages of a trial to identify and coordinate the management of adverse events. Our emphasis on employing strict safety reporting guidelines from the design stage ensures the quality and efficiency of the service we deliver to sponsors and the safety of patients who participate in our trials. Our Medical Monitors work closely with the safety team and help to oversee safety reporting activities and management of adverse events for our trials.
Our Safety and Pharmacovigilance team operate in Australia China, India, Japan, Korea, Hong Kong, Taiwan, New Zealand, and Malaysia.
Our experienced Safety and Pharmacovigilance team provides:
- Full Safety Service capabilities including safety database
- Tailored solutions for commercial & academic research across all phases
- A service that is adaptable, yet able to maintain the highest regulatory and ethical compliance
- A thorough understanding of Safety Reporting Requirements across trial countries
George Clinical utilises Tools for Adverse Reaction Assessment (TARA) for global safety management. TARA is a web-based, fully validated, ISO 9001 accredited, 21 CFR Part 11 compliant pharmacovigilance system. TARA provides all the functionality required to manage adverse event collection and reporting duties, providing an extensive list of capabilities, including but not limited to, producing necessary regulatory reporting formats for global safety submissions (including CIOMS-I, CIOMS-II, Medwatch, VAERs and E2B), dictionary input and access (including WHO, MedDRA, and PubMed), and data extracts in various formats (*.xml, *.csv, *.xls) suitable for integrations into other clinical systems. TARA is extremely versatile, facilitating faster and easier management of adverse reactions with a configurable workflow, customisable console, and straightforward end user and administrative setup, TARA can be implemented for a single clinical trial or can form the central safety management system for a clinical development programme and lifecycle management.”