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A Contract Research Company that integrates with a Clinical Research Network into part of a healthcare company.
Scroll downGenesisCare 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.
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:
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.
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.
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.
Eight (8) research sites across Brisbane, Bundaberg, Melbourne, Adelaide and Perth. See research site map and “Site CVs” documented in TransCelerate’s Facility Form:
Trained clinical research staff, nurses, cardiac physiologist, administration staff and over 90 cardiologists
Over 30 Clinical Research Network staff
Conducted over 120 trials in the last 10 years
Currently involved in approximately 40 ongoing research studies
MAVERIC (mitral valve repair), AMULET (atrial fibrillation), (CLEAR) (CV Events), GALACTIC (CHF), ONYX (anti-platelet)
36 Sites (33 radiation oncology, 3 medical oncology). See “Site CVs” documented in TransCelerate’s Facility Form below
Approximately 23 Clinical Research Network staff with a further 7 at the newly acquired medical oncology sites, Northern Cancer Institute (NCI)
Approximately 6% industry sponsored
Currently involved in approximately 110 ongoing research studies with 56 actively recruiting (excluding NCI) 59 studies at NCI
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.
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.
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.
