Critical to a successful clinical trial is the efficient management and site monitoring of clinical sites. George Clinical has an exceptional record in risk-based clinical trial monitoring, which ensures scientific excellence and data integrity across all sites.
George Clinical engages a diverse range of specialised staff to perform all aspects of site management and monitoring throughout our many operational centres and regional hubs. George Clinical has the scale to facilitate clinical site management services throughout the Asia-Pacific and in most corners of the globe.
Our in-house operational personnel are based globally and throughout the Asia-Pacific region, not only to limit travel and support the project team, but primarily to leverage local knowledge of the clinical research and regulatory environments.
George Clinical offers an experienced team of regionally based monitors, all with top in class oncology and monitoring experience. Our global clinical research associates (CRAs) focus on developing strong site relationships while ensuring their adherence to data quality, subject safety, and early issue resolution throughout the course of the trial. Comprehensive monitor plans are crafted to address the trial complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring tactics.
Clinical Trial Monitoring activities include:
- Full service monitor visits – qualification, initiation, routine, and close-out
- Comprehensive monitor plans
- In country expertise for feasibility or regulatory submissions
- Thorough review of site records
- Timely completion of visit reports
- Quality review of monitor reports
- Source document verification as per monitor plans
- Rapid query resolution
- Site training and support
- Site management support & documentation
- Periodic remote EDC review
- Drug accountability
George Clinical has taken a leadership role in the application of risk-based monitoring, the streamlined approach to monitoring clinical trials, increasingly preferred by a number of influential regulatory bodies. George Clinical’s pioneering application of risk-based monitoring has seen our sponsors receive better quality data at a lower cost. The results generated by George Clinical are delivered in a timely fashion due to the centralization of information. The multi-site comparisons and centralized data collection allows for the identification of outliers, the early identification of risks and the immediate resolution of site issues.
Some of our clinical site management services include:
- Site selection and feasibility
- Development of recruitment criteria
- Managing patient recruitment
- Inbuilt quality assurance mechanisms
- Assurance of Good Clinical Practice
- Communication with sites
- Customizable training based on the needs of the study
- Managing of local ethics review processes
Our Site Management team operates globally and has unique expertise in Australia, China, India, Japan, Korea, Hong Kong, New Zealand, the Philippines and Malaysia.
George Clinical – Risk Based Monitoring
With such large data sets, it’s difficult to identify outliers and risks before it’s too late.
That’s why George Clinical implements risk-based monitoring; identifying risks and developing solutions early, saving you time and money.
The multi-site comparisons and data centralization allows for the identification of outliers, early identification of risks and focused resolutions of site issues.
Learn how risk-based monitoring can be implemented into your trial at www.georgeclinical.com