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
Integrated model of Clinical Research Network and CRO embedded in a health care company
International, private Clinical Research Network with:
state of the art equipment
standardised treatment pathways
CRO research capabilities tailored to facilitate research in therapeutic areas of GenesisCare’s specialisation
Advanced information technology platform with eMR and patient reported outcomes capability allowing:
extraction of Real World Data
construction of registries
support for commercialisation
Nuclear Medicine Services:
Australia R&D Tax Incentive
GenesisCare CRO provides full Australian delivery to help leverage the full benefits of the R&D Tax Incentive
A 43.5% refundable tax offset for eligible expenditure for companies with a turnover <$20 Million A 38.5% non-refundable tax offset for eligible expenditure for companies with a turnover >$20 Million
Eligible for companies that have a registered entity in Australia. Incentive applies to all services completed within Australia (labour and passthrough costs). Legal entity takes approx. 6-8 weeks to set-up
May be eligible for overseas finding in cases where services cannot be done in Australia or patient population in Australia is rare (ex. Preclinical toxicology or rare or low incidence rate of a disease or condition
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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
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
Data management and biostatistical services involved from protocol build to final output
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.
Clinical Research Network Sites
Heart Care Research
Eight (8) research sites across Brisbane, Bundaberg, Melbourne, Adelaide and Perth. See research site map and “Site CVs” documented in TransCelerate’s Facility Form:
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)
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.
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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.
Make an enquiry
Get in touch if you would like more information about our CRO services or Clinical Trial Network.
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.