Who are we?

GenesisCare Clinical CRO is an independent company founded by GenesisCare, with people skilled across the full spectrum of traditional CRO service offerings yet connected through GenesisCare to additional research services and investigator sites.

What we offer

Why partner with GenesisCare Clinical CRO?

We offer a unique model integrating a Contract Research Organisation with our Clinical Research Network as well as a bespoke model to fit each client’s needs. Our integrated model leads to faster, better designed and cost-effective drug development:

  • direct to site communication and transparency
  • rapid access to information on patient availability (e.g. eMR)
  • better study feasibility & site selection
  • better patient recruitment & retention
  • faster escalation & resolution of issues
  • improved investigator/site engagement
  • key opinion leader input into study design & reporting
  • access to “Real World Data” & patient registries

Single point of contact for the CRO and Clinical Research Network

We are not restricted to the use of GenesisCare sites, however, advantages lies within our integration.

Our point of difference

versus other contract research models
  1. Integrated model of Clinical Research Network and CRO embedded in a health care company
  2. International, private Clinical Research Network with:
    • state of the art equipment
    • standardised treatment pathways
  3. CRO research capabilities tailored to facilitate research in therapeutic areas of GenesisCare’s specialisation
  4. Advanced information technology platform with eMR and patient reported outcomes capability allowing:
    • extraction of Real World Data
    • construction of registries
    • support for commercialisation
  5. Nuclear Medicine Services:
    • dosimetry
    • central imaging

Data and Innovation

The CRO leverages GenesisCare's newly established division to accelerate innovation

GenesisCare has established electronic medical records eMRs and applications to allow patient reported outcomes in the therapeutic care pathways for radiation oncology and cardiovascular patients.

In the oncology therapeutic area, physician-led Tumour Reference Groups are standardising the treatment pathways and creating Minimum Data Sets (MDS).

MDS form the basis of data registries used for clinical research.

A hands-on approach

Clinical Services

Empowered project managers and clinical teams to partner together to deliver on timelines and budgets

Medical Services and Safety

Extensive in-house medical expertise and pharmacovigilance services from protocol inception to Clinical Study Report delivery

Biometrics

Data management and biostatistical services involved from protocol build to final output

Quality

Strong quality measures put in place from award to ensure appropriate training, review and adherence to regulations

CRO Project Manager coordination of all services for Clients

The CRO Project Manager coordinates all GenesisCare Clinical CRO services for the Client as well as services required from any external vendors, GenesisCare’s  Research Network, GenesisCare’s Nuclear Medicine Services and Central Imaging Services. The Project Manager also coordinates any required non-GenesisCare sites. Independent Quality Assurance oversight is provided by GenesisCare Quality Assurance team.

GenesisCare; Diagram of Clinical Research Ops

Clinical Research Network Sites

Heart Care Research

  1. Australian Sites

    Eight (8) research sites across Brisbane, Bundaberg, Melbourne, Adelaide and Perth. See research site map and “Site CVs” documented in TransCelerate’s Facility Form:

  2. Sites have access to:

    Trained clinical research staff, nurses, cardiac physiologist, administration staff and over 90 cardiologists

  3. Staff

    Over 30 Clinical Research Network staff

  4. Trials

    Conducted over 120 trials in the last 10 years

  5. Research studies in Australia

    Currently involved in approximately 40 ongoing research studies

  6. Key trials

    MAVERIC (mitral valve repair), AMULET (atrial fibrillation), (CLEAR) (CV Events), GALACTIC (CHF), ONYX (anti-platelet)

Sonya McColl

National Research Manager

Professor Stephen Worthley

FRACP, FACC, FCSANZ, FRCP

As Executive Manager, Steve leads a network of over 80 Cardiologists and 6 Practices located in all mainland states of Australia. As part of his role he also fosters our research program through the GenesisCare Research Network.

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Cardiovascular outcomes registries

  • GenesisCare registries aim to improve patient outcomes
  • They provide significant Real World Data with the potential to address research questions
  • Registries have been established in:
    • Patients undergoing angioplasty (PCI Registry)
    • Patients undergoing a cardiac implantable device (pacemaker or defibrillator) (Device Registry)
    • Patients attending heart failure clinics (Heart Failure Registry)
    • Patients undergoing cardiac imaging procedures (Echo Data base)

Clinical Research Network: Cancer Care Research

  1. Australian Sites

    36 Sites (33 radiation oncology, 3 medical oncology). See “Site CVs” documented in TransCelerate’s Facility Form below

  2. Staff

    Approximately 23 Clinical Research Network staff with a further 7 at the newly acquired medical oncology sites, Northern Cancer Institute (NCI)

  3. Trials

    Approximately 6% industry sponsored

  4. Research studies in Australia

    Currently involved in approximately 110 ongoing research studies with 56 actively recruiting (excluding NCI) 59 studies at NCI

  5. International Clinical Research Network Sites

    21st Century Oncology in the USA became part of GenesisCare in 2020 extending the research network. Read more here. GenesisCare is also establishing research sites in the UK and Portugal.

Radiation Oncology Sites

  • GenesisCare Cancer Care Research (Bundaberg)
  • GenesisCare Cancer Care Research (Chermside)
  • GenesisCare Cancer Care Research (Hervey Bay)
  • GenesisCare Cancer Care Research (Southport)
  • GenesisCare Cancer Care Research (Tugun)
  • GenesisCare Cancer Care Research (Wesley)

  • GenesisCare Cancer Care Research (Calvary)
  • GenesisCare Cancer Care Research (Flinders)
  • GenesisCare Cancer Care Research (St Andrews)
  • GenesisCare Cancer Care Research (Tennyson)

  • GenesisCare Cancer Care Research (Albury)
  • GenesisCare Cancer Care Research (Berwick)
  • GenesisCare Cancer Care Research (Cabrini)
  • GenesisCare Cancer Care Research (Epping)
  • GenesisCare Cancer Care Research (Frankston)
  • GenesisCare Cancer Care Research (Ringwood)
  • GenesisCare Cancer Care Research (Shepparton)

Medical Oncology Sites

  • GenesisCare Cancer Care Research (NCI, St Leonards)
  • GenesisCare Cancer Care Research (NCI, French’s Forrest)
  • GenesisCare Cancer Care Research (Hurstville)

A/ Professor Peter O'Brien

MMBS, FRANZCR Executive Manager Oncology

Peter O’Brien is a radiation oncologist with more than 20 years’ experience in the treatment of cancer and research into improving treatment. He has a particular interest in the management of breast and gynaecological cancer, sarcoma and lymphoma and is actively involved with multi-disciplinary care for all of these tumour types.

Sonya McColl

National Research Manager

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Nuclear Medicine Services and Central Imaging

The GenesisCare Nuclear Medicine and Central Imaging Service (NMCIS) provides dosimetry and central reading services fully integrated with the Clinical CRO. The collective experience of our team of experts accredited in clinical nuclear medicine, radiology, physics, dosimetry, radiochemistry and radiobiology are supported by meticulous CRO project and data management to support the design and execution of world-class pre-clinical and clinical studies. Our scientific team provides a range of bespoke services including technical site support for imaging trials, optimisation of imaging parameters, and dosimetry, biodistribution and pharmacokinetics determination. Our dosimetric service is FDA-compliant, allowing modelling and kinetic outputs to be incorporated directly into FDA submissions.

Our experts in nuclear medicine and radiology work alongside our image and data managers in our core lab to support trials with imaging end points. We offer consulting services for image acquisition and image reading protocol design, secure imaging data transfer, robust quality control processes and image reading on an FDA-approved image reading platform. We understand that experience and expertise is key to high quality image interpretation and data capture and make it our priority to allocate the right readers to the right study.

Danielle Meyrick PhD, MD

Danielle is a clinically active medical practitioner, holding an MD from the University of Western Australia and general registration with AHPRA. She also has a PhD in radiopharmaceutical chemistry, and has worked extensively in the preclinical development and clinical application of novel diagnostic and therapeutic pharmaceuticals. Danielle combines her clinical and technical experience to support study design and execution that is both practical and scientifically sound, producing clinically relevant outcomes.

Make an enquiry

Get in touch if you would like more information about our CRO services or Clinical Trial Network.
Get in touch

Helen Ormandy PhD BSc(Hons) BLaws(Hons) Grad Dip HECON

Head of Global Clinical Operations CRO

Helen has over 30 years of experience in drug development and has held senior positions in global roles within the pharmaceutical /biotech industry, CRO and Medical Research Institute  environment. She has operational experience across many therapeutic areas including oncology and cardiovascular, and in early phase trials.  This broad perspective positions her well to understand and support client needs as Global Head of the CRO.

Our Australian research sites

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Murdoch (Oncology)

St John of God Murdoch Hospital, Barry Marshall Parade, Murdoch WA 6150

Hollywood - Coming soon (Oncology)

Hollywood Consulting Centre, Hollywood Private Hospital, Entrance 5, Unit 1, 91 Monash Avenue, Nedlands WA 6009

Kingswood (Oncology)

38 Somerset St, Kingswood NSW 2747, Australia

(02) 4726 8700

Shepparton (Oncology)

124 Corio St, Shepparton VIC 3630, Australia

(03) 5825 9700

Concord (Oncology)

375A-377 Concord Road Concord West NSW 2138

(02) 8399 9600

Mandurah (Oncology)

Unit 3/35 Minilya Parkway, Greenfields WA 6210

(08) 9559 2900

Cabrini (Gandel Wing)

Cabrini Hospital Malvern, Level B4, Gandel Wing, 183 Wattletree Road, Malvern, VIC 3144

(03) 9597 6900

Hollywood Private Hospital (Theranostics)

Hollywood Private Hospital, Diagnostic Nuclear Imaging, Monash Ave, Nedlands WA 6009

(08) 9438 8500

Friendly Society Private Hospital Bundaberg (Cardiology)

Floor 1, 19-23 Bingera Street, Bundaberg QLD 4670

(07) 4199 7300

Wesley Hospital Auchenflower (Cardiology)

Level 5, Suite 91 Sandford Jackson Building 30 Chasely Street Auchenflower QLD 4066

(07) 3858 8650

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