Who are we?
GenesisCare’s Clinical CRO is an independent company within GenesisCare, providing contract clinical research services. As a global full-service CRO, we provide tailored clinical development solutions spanning the entire lifecycle of product development, with deep expertise in oncology and theranostics. Leveraging the expertise of our global physician and site network, we deliver faster, more cost-effective and efficient trials for clinical development for our customers.
Our unique, integrated CRO and SRO network model, translates into:
- Access to a large patient population and information on patient availability, for study feasibility & site selection
- Access to global site network, facilitating improved patient recruitment & retention.
- Improved investigator and site engagement - Key opinion leader input into study design & reporting
- Access to Real World Data & patient registries
- Direct to site communication and transparency
How we partner
GenesisCare’s Contract Research Organisation is an independent company founded by GenesisCare. We provide tailored bespoke services across all clinical trial phases for our customers.
One of the key benefits of our network is that we can provide customers with a fully integrated solution, comprising of our CRO, SRO and Imaging Research Organisation (IRO). However, as a Contract Research Organisation and Imaging Research Organisation, we are site and company agnostic, and also work routinely with other site research organisations, academic institutions, and hospital networks. Our Site Research Organisation is also CRO agnostic and can also work with other CRO’s.
Imaging Research Organisation:
GenesisCare’s CRO is home to a dedicated Imaging Research Organisation (IRO), specialising in the provision of comprehensive imaging services to support oncology and theranostics research. Our IRO services include full-service central imaging, comprehensive nuclear medicine consultancy and dosimetry services for radiopharmaceutical development.
GenesisCare’s IRO offers clients end-to-end tailored imaging and dosimetry services throughout all stages of the clinical trial process for oncology and theranostics research:
- Bespoke imaging and dosimetry consultation for protocol writing
- Imaging Manual and Charter Preparation
- Site and Reader selection and training
- Streamlined image receipt, QC and query resolution
- Imaging quantification and dosimetry
- Central image review across all imaging modalities, including PET, SPECT, CT, MRI
We understand the importance of imaging protocol and its criticality in meeting imaging endpoints. GenesisCare’s IRO provides clients with imaging protocols tailored to the need of each trial for image quality optimisation and standardisation across multiple sites. Key services include
- Site Imaging Manual preparation and site training
- Optimisation of PET/CT and SPECT/CT image acquisition and reconstruction
- Scanner validation for diagnostic and therapeutic trials
- Extensive experience with diagnostic and therapeutic radionuclides
With our team of experienced technologists and physicists, GenesisCare’s IRO are the experts in image quantification and dosimetric calculations for radiopharmaceutical development. Key services include:
- Vendor-neutral SPECT image reconstruction and quantification
- Dosimetry based on 2D planar, 3D SPECT/PET or hybrid 2D-3D imaging
- MIRD style phantom organ S-values methodology
- Voxel S-values methodology for patient-specific dosimetry
- Biological equivalent dose (BED) modelling for radiopharmaceuticals
- Extrapolation of dose from surrogate to therapeutic radionuclides
We understand the importance of central image reviews for imaging endpoints in oncology and theranostics trials where imaging is involved. GenesisCare’s IRO provides clients bespoke central imaging services that include:
- Image Review Charter preparation, reader selection and training
- Central image reads by experienced Nuclear Medicine Physicians and Radiologists for imaging endpoints
- Expert advice from experienced clinical trialists for central read design
Our experienced team of physicians, physicists and technologists, provide comprehensive theranostics technical support and have extensive experience with development of diagnostic and therapeutic radiopharmaceuticals. We provide guidance and advice on current best practices for theranostics trials.
Our partner promise:
Since our inception in 2018, we have become a trusted partner of choice to pharmaceutical, biotechnology, medical device sponsors, as well as leading academic institutions and tertiary hospitals.
We believe great things happen for our patients when like-minded organisations come together to innovate, collaborate, and shape the future of cancer care.
Our networked nimble approach to clinical research allows us to provide tailored solutions to meet the needs of each individual sponsor.
We are committed to operational and clinical excellence throughout all stages of drug development.