Clinical Trial Management
Our staff can manage all aspects of eye clinical trials (phase I-IV) from design to publication, according to your needs. We are experienced in all associated activities including study feasibilities, project management, monitoring, medical writing, biostatistics and safety management.
We can provide:
- A single site/centre providing fast start-up, high recruitment and quality data.
- Coordination of an Eye Trials Research Network to expand access to private eye research sites who benefit from our training, certification and oversight.
- Tailored eye examinations/vision assessments to assess potential adverse reactions, e.g. oncology drug-development. We are currently collaborating with the Austin hospital on an adenocarcinoma trial.
Retinal Vascular Imaging Centre
The Retinal Image Grading Centre (formally the Retinal Vascular Imaging Centre – RetVIC) welcomes collaborative grading projects or can provide a fee for service grading.
Retinal images can be assessed for signs of retinal conditions such as diabetic retinopathy, age-related macular degeneration and general retinal pathology. Semi-automated software can be used to grade retinal images for an array of novel retinal vascular parameters including: calibre, tortuosity, branching angles and fractal dimension. The retina is the only site where blood vessels can be viewed non-invasively and these novel vascular measures can be used to investigate associations between changes in the retinal microvasculature and the systemic vasculature.
Our graders are highly trained experienced in all types of grading. All graders hold the International Certificate of Higher Education in Diabetic Retinopathy Screening from the University of Gloucestershire. They are amongst the first in Australia to be awarded the certificate and are experienced in coordinating and performing a diabetic retinopathy screening service. They have conducted grading for many large studies including CERA’s recent National Eye Health Survey (2015/16).
Grading services include:
- Advising which grading measures best suit your required outcomes and which images are required to achieve this
- Photographer training and certification for external staff
- Non-mydriatic photography and OCT capture (conducted at CERA only)
- Loans of non-mydriatic cameras (limited availability)
- Grading semi-automated software training and certification of external staff
- Grading of images
For further information, please contact Lauren Hodgson at: email@example.com
Visual Acuity Training and Certification Service
Out team provides visual acuity training and certification for other sites to ensure a high level of consistency and quality across sites participating in eye research studies. For further details please click here.
Our statisticians each have over ten years of experience analysing data from eye research studies. Statistical input proves useful at every stage of research from study design decisions including sample size calculations and data structure through to multivariate analysis. Previous projects have included: analysing large international cohort study datasets, pooling epidemiological datasets for meta-analysis and assessing efficacy in clinical trial data.
We have successfully run a 2 day face-to-face GCP course for 3 years that is TransCelerate-approved, certification is valid for 2 years.
In 2017 we will run a 4 hour face-to-face TransCelerate-approved course for busy clinical trial staff and clinicians. Click here for further details.
The costs for all our services are competitive and in keeping with “fair market value”. We maintain a fee schedule across the Clinical Trials Research Centre (CTRC) and CERA to ensure consistency and transparency.
This schedule assists with faster budget negotiation and site start-up times. We can negotiate the budget on behalf of Eye Trial Research Network sites.
We are a not-for-profit research organisation with any surplus generated being invested back into research.
Space and Facilities
The main clinical trial area of the Clinical Trials Research Centre is located on the Upper Ground Floor, Eye and Ear on the Park. It is equipped for comprehensive eye examinations, imaging, collection of biological specimens and intravitreal injections. A processing lab for biological samples and drug storage within the unit are available. The area meets all regulatory and safety requirements for the conduct of drug trials.Offices for staff and industry monitors required to support trial activities are located on the same floor. The area provides the necessary security and confidentiality requirements for the management of clinical trials data and is regularly audited. Meeting, education and training rooms are also available.
The patient waiting area can comfortably accommodate large numbers of patients. Guide dogs are welcomed.