George Clinical
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| George Clinical | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2005 |
| Headquarters | Level 5, 1 King Street, Newtown, NSW 2042 Australia |
| Number of employees | 201-500 |
George Clinical is a leading clinical contract research organisation company in Asia with over 260 global staff. George Clinical provides the full range of clinical trial services to pharmaceutical, medical device and biotech customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service CRO.
Contents
History
Parent Organization : The George Institute for Global Health, is a leader in chronic disease research, with a global network of experts with whom George Clinical engages.
Services
- Clinical Operations Services
- Clinical Monitoring & Site Management
- Scientific Leadership & Investigator Management
- Program & Protocol Design
- Project Management
- Data Management
- Safety & Pharmacovigilance Services
- Medical Monitoring
- Quality Management
- Endpoint Adjudication
- Statistics Services
- Health Economics
- Regulatory Services
- Medical Writing
Safety & Pharmacovigilance Services
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. safety and pharmacovigialnce
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.”
Top 5 Recent Tweets
{{#George Clinical @george_clinical May 31
Don't miss out on meeting our #oncology experts Drs Lee Schwartzberg and Ari VanderWalde and CEO Marisa Petersen at #ASCO17 Chicago June 2-6:}}
Top 5 Recent News Headlines
George Clinical buys up CRO unit from Vector Oncology, boosting its operations [1]
Top 5 Lifetime Tweets
Top 5 Lifetime News Headlines
- ↑ http://www.fiercebiotech.com/cro/george-clinical-buys-up-cro-unit-from-vector-oncology-boosting-its-ops
Top Authors
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