CERA

Clinical trials

Our research capabilities

We are equipped to perform a range of eye research methodologies and surgeries, with an experienced team including ophthalmologists, orthoptists, nurses, statisticians and data scientists .

Overview

Our clinical trials teams can provide:

  • Expert clinical advice from world renowned key opinion leaders
  • Clinical study expertise from phase I-IV studies and with drug, device and observational studies
  • Visual acuity examiner and visual acuity room certification
  • Coordination of private eye research study sites
  • Biostatisticians specialised in eye research
  • TransCelerate-accredited Good Clinical Practice (ICH-GCP) training courses
  • Ophthalmic services and support to external research centres conducting trials in various phases and disease types.

Eye research clinical methodologies

As one of the top five global eye research groups, we perform a range of eye research methodologies and surgeries.

Patient examinations and imaging include:

  • Refraction and Best Corrected Visual Acuity
  • Reading Speed Testing
  • Low Luminance Visual Acuity Testing
  • Intraocular Pressure
  • Pachymetry
  • Colour Vision Testing
  • Humphrey Visual Field Testing
  • Anterior Segment Imaging
  • Physical examinations (including blood pressure, height, weight, ECG)
  • Optical Coherence Tomography Angiography (OCT-A)
  • Spectral Domain Optical Coherence Tomography (SD-OCT)
  • Fluorescein Angiography and Indocyanine Green Angiography
  • Microperimetry
  • Fundus Autofluorescence
  • Colour Fundus Photography
  • Electroretinogram (ERG)
  • Biological sample testing
  • Dark Adaptation Perimetry

We also have access to the Royal Victorian Eye and Ear Hospital for additional specialist testing.

Our quality framework

All CERA’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.

We have been audited three times by sponsors, mostly recently in November 2016, with minimal findings.

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

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.

High recruitment and quality research data

We are proud of our record:

  • Meeting or exceeding recruitment targets in 87 per cent of all studies
  • Successful Human Research Ethics Committee (HREC) submissions, with median approval time of two months
  • Fast start-up times to First-Patient-In (FPI) after HREC approval
  • Successful audits, with our most recent sponsor audit producing no study related findings
  • 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, only 9 per cent of patients were lost to follow-up
To learn more about collaborating on clinical trials with us, give us a call on +61 3 9929 8360 or email [email protected]