Cerulea Clinical Trials

For industry

Our services

We are a trusted research partner providing quality services for sponsors and investigators, with swift start up and recruitment, excellent retention rates and support for decentralised trials.

Our quality framework

All of Cerulea’s investigators and study coordinators hold current TransCelerate-accredited qualifications for Good Clinical Practice (ICH-GCP).

Our standard operating procedures (SOPs) ensure that all staff are equipped to lead and manage clinical studies to global regulatory standards.

We conduct internal quality control processes regularly and are prepared for external audits at any time.

Cerulea Clinical Trials adheres to the principles and practice outlined in the Australian National Statement on Ethical Conduct in Human Research (2024), Australian Code for the Responsible Conduct of Research (2018) and work within the Australian Research Data Management Framework for Institutions (2023).

We also monitor, train and certify other eye research sites.

High recruitment and quality research data

Our strong relationships with eye care professionals and participant advocacy groups provide access to a broad pool of potential trial participants. Our co-location in the Royal Victorian Eye and Ear Hospital, strong relationships with private ophthalmology clinics and access to large cohorts from natural history studies for age-related macular degeneration and inherited retinal disease help us recruit the right participants for the right studies.

We are proud of our track record which includes:

  • Meeting or exceeding recruitment targets in 87 per cent of all studies
  • Consistent and reliable Human Research Ethics submissions, with median approval time of 6 weeks. Cerulea Clinical Trials works collaboratively with St Vincent’s Health Institutional Biosafety Committee and Ethics Committees as well as Bellberry Ethics Committees.
  • Fast start-up times to First-Patient-In (FPI) after HREC approval
  • Successfully recruiting participants for landmark eye research studies including:
    • Neo-vascular Age-related Macular Degeneration (ANCHOR, EXCITE, SUSTAIN, VIEW II, PIER, MARINA studies)
    • Central Retinal Vein Occlusion (GALILEO study)
    • Diabetic Macular Oedema (MACUGEN, RESOLVE, RESTORE, VIVID, Posurdex studies)
    • Uveitis (VISUAL I, II and III studies)
  • Excellent retention rates: in our longest study with a 9-year follow-up, with only 9 per cent attrition.

Decentralised trials

Our Eye Research Network grows month-on month, with a plan to extend further into remote and regional areas providing an opportunity for more people to participate in research opportunities, improves retention and increases access for clinicians to emerging therapies and to be involved in the latest ophthalmic research.

The network supports a growing network of private practices specialising in eye research and draw on the support of our mobile study coordinators and medical coordinators to coordinate, train and certify staff in their private practices.

Our mobile study coordinators can support studies with:

  • Site feasibilities
  • HREC, regulatory and safety submissions and reporting
  • Contract and budget negotiations and finance management
  • Investigational product management
  • Preparation and management of source documents and other study documents
  • Patient recruitment, consent and scheduling
  • Data-entry and query resolution
  • Quality control in line with Cerulea’s Quality Framework.

Design through to publication of investigator-initiated studies

We can:

Design clinical studies

  • Write investigator brochures, study protocols, clinical study reports and manuscripts
  • Prepare budgets, manage study finances and agreements
  • Train site and study personnel in Good Clinical Practice
  • Manage investigational product
  • Manage all ethics, regulatory and safety submissions and reporting requirements
  • Create databases, enter, clean and statistically analyse data
  • Manage quality through risk-assessment and management, site monitoring, and by training of our own staff and other sites.

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 fully owned subsidiary of the Centre for Eye Research Australia (CERA), all of our revenue is invested back into vision research at CERA as well as invested in creating a better experience for trial participants,  clinicians and sponsors and into new equipment and services that can be utilised by trial sponsors and clinician-researchers.

To learn more about collaborating with Cerulea Clinical Trials contact +61 3 8638 5300 or info@ceruleaclinicaltrials.org.au