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The Clinical Research and Trials Centre has a dedicated team experienced in conducting a range of small and large-scale clinical trials for industry to Australian and international standards.
Capabilities and Options
Clinical trial types
The Clinical Research and Trials Centre has extensive experience conducting the following types of trials:
- Pilot/feasibility
- Pivotal
- Post-market
as well as:
- Benchmarking
- Manufacturing/design support
Specific clinical trial capabilities include:
- Trial feasibility
- Project planning and management
Essential document preparation include:
- Protocols
- Informed consents
- Recruitment tools
- Human Research Ethics Committee (HREC) application and submissions
- Regulatory Clinical Trial Notification (CTN) submissions
Case report forms or electronic direct data entry system
Recruitment
Event reporting
Data management, including entry, analysis and storage
Reporting:
- Trial updates
- Interim analysis
- End of clinical trial reports
Clinical Excellence
The Clinical Research and Trials Centre works to international and local clinical trial standards (including ‘Good Clinical Practice’ and the ‘National Statement on Ethical Conduct in Human Research’) as well as Standard Operating Procedures (SOPs). All staff are supported by the provision of regular training for these and their individual position responsibilities. For more information on Standards click here.
Clinical trial optometrists maintain clinical concordance as well as ongoing optometric skills training to ensure consistency and reliability in clinical observations.
Clinical compliance oversight is provided by a Clinical Compliance Manager and Clinical Research Associate.
The Clinical Operations team works across all research projects ensuring that smooth and efficient operations and data integrity are upheld. All clinical trials are reviewed by an independent Human Research Ethics Committee to ensure the highest standards of ethical performance are followed.
Comprehensive Participant Register
The Centre has invested significantly in building a comprehensive trial volunteer participant database. Drawn from a range of ages and backgrounds, all participants on the database have undergone pre-trial screening to ensure general suitability for clinical trials, and therefore recruitment needs can be met expediently and quickly.
In addition, the Institute has two overseas collaborators for trials that require special populations and offer the option of larger enrolment numbers. These are:
India: The LV Prasad Eye Institute, Hyderabad
China: The Zhongshan Ophthalmic Centre at Sun Yat-Sen University, Guangzhou
Trial Information Management
The Clinical Research and Trials Centre has extensive experience in the collection and presentation of information, providing both summaries and detailed data to meet client needs.
Data can be electronic or paper-based, and in-depth analysis of clinical data is supplemented by specialised techniques. These techniques include video capture, image analysis, metrology and computer modelling.
The Centre has a custom-built database that allows direct data entry, simplified review and extensive analysis in a highly efficient manner and economical timeframe.
Insight
While quality data is the essential basis for successful research activities, interpretation and insightful reporting of data are the keys to effective decision making and efficient product development.
Personnel at the Clinical Research and Trials Centre have extensive experience in the contact lens and related technology fields, and can provide sophisticated evaluations of research results.
We can also provide additional insight into your product by a number of approaches, depending on your requirements:
- Analysis of end product quality related to design and manufacturing changes
- Benchmarking
- Marketing support
Multidisciplinary Expertise
In addition to the strong clinical team in the Centre, the Brien Holden Vision Institute has access to a wide range of complimentary scientific services on site provided by the Science and Technology disciplines.
These include:
- Microbiology
- Biochemistry
- Immunology
- Cell and molecular biology
- Instrument design and development
- Precision optical and biomedical engineering
- Software development and engineering - especially in data and image acquisition and analysis
- Metrology work, specialising in ophthalmic and optical components and devices.
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Research 
