Clinical trials

Our services

CERA provides a number of research services, from clinical trial management through to visual acuity training and more.

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 which 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.

Support through the Eye Trials Research Network

We support a growing network of private practices specialising in eye research. Ophthalmologists can join the Eye Trials Research Network and draw on the support of our mobile study coordinators and medical staff to coordinate, train and certify staff in their private practices.

Our mobile study coordinators can support eye research studies including:

  • Site feasibilities
  • HREC, regulatory and safety submissions and reporting
  • Contract and budget negotiation, finance management
  • Investigational product management
  • Preparation and management of source documents and other study documents
  • Patient scheduling
  • Data-entry and query resolution
  • Quality control including site set-up, monitoring and close-out
  • Training and certification of staff in eye exams and ICH GCP.

Statistical support

Each of the Centre’s statisticians have more than ten years experience analysing data from eye research studies.

Statistical input is essential 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.

Competitive costs

The costs for all our services are competitive and offer fair market value. Our fee schedule is consistent and transparent, and assists with faster budget negotiation and site start-up times. We can negotiate the budget on behalf of Eye Trial Research Network sites.

As a not-for-profit research organisation, any surplus is invested in further research.

To learn more about collaborating on clinical trials with us, give us a call on +61 3 9929 8360 or email cera-trials@unimelb.edu.au