Clinical Research Organisation (CRO)

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.

Strategic Clinical Development Consulting

Deep and broad expertise in planning therapeutic development pipelines and operationalising protocols. Our consulting services start the very first day you engage us on a potential project. We are able to provide the relevant input, in-country knowledge, and expertise to enable our customers to execute the right protocol strategy for their projects.

Project Management

We provide start-to-finish project management services for clinical studies to drive operational efficiencies and maintain patient safety and data integrity. Our dedicated team of project managers will become your key contact throughout all stages of the project and will be deeply embedded in your team. We provide a complete 360 project management solution, including all aspects of status reporting, budget, third-party vendors and milestone management.

Data Management

Accurate and reliable clinical data allows us to assess whether a study’s primary and secondary endpoints have been achieved and is also the key component of any application for regulatory approval. We look to take data management off the critical path with an innovative and agile approach to cater to different protocol complexities. We work with industry standard electronic data capture (EDC) platforms, including Veeva EDC and Viedoc EDC.

Our flexible clinical data management solution includes:

Database design and development
Provision of CDISC/SDTM compliant datasets
Medical coding
Data transfer and API integrations
Query design and validations
Preferred EDC platforms
Data reconciliation (including SAE reconciliation)
De-identification of data
Study status Reporting

Site Management and Engagement

Our philosophy and approach to clinical trial site management and engagement isn’t like your typical CRO. Our integrated site research network, spanning more than 350 centres across the globe, gives us a unique, fresh perspective on site management. We understand the very real, practical challenges faced by trial sites and on-the-ground teams, and anticipate and resolve potential roadblocks before they arise.

Our services include:

Investigator recruitment and ongoing engagement
Site identification and feasibility studies, site selection and qualification
Site Initiation
Site personnel training and education
Management of patient recruitment
Therapeutic supply logistics
Monitoring of clinical trial data
Direct-to-site communication

Quality Assurance

GenesisCare’s highly experienced global Quality Assurance team has deep and broad experience in all areas of quality assurance and knowledge of GCP guidelines and in-market local regulations. To ensure a seamless integration with our customers own QA systems and processes, we have invested in a quality management system routinely used by pharmaceutical, biotech, and medical device companies, and we are ISO9001 certified. Our QA service offering includes clinical site, protocol and clinical database audits, as well as providing support to our clients for regulatory bodies inspections.

Pharmacovigilance

At GenesisCare, our global team of Pharmacovigilance (PV) experts manage the safety and pharmacovigilance needs of clients throughout all stages of product development.

Our PV services for Phase I-III development include:

SAE reporting
SAE processing
Narrative writing
Medical review
Lab and diagnostics test review
Safety report distribution and submission
Expertise in all major systems

Our PV team work with industry standard platforms to manage case reporting, including the TARA PV platform.

Biostatistics

GenesisCare partners with leading biostatistics service providers, who work in close collaboration with the data management and project management teams throughout all stages of a study.

Our services include sample size estimation and review of methodology, statistical analysis, rapid data delivery, access to all compatible data formats and files, and clinical study report delivery.

Medical Writing

We offer end-to-end clinical research communication services, built from a comprehensive understanding of in-country regulatory guidelines and scientific communication expertise.

Our medical writers work closely with other key functions, including Biostatistics, Quality Assurance, and Clinical Operations, to ensure timely and efficient information transfer.

Our medical writing services include:

Regulatory: writing and submissions
Clinical study protocols and amendments
Informed consent writing
Publications and abstracts
Investigator educational material
Clinical study report writing

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.

End-to-end imaging and dosimetry services:

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

Imaging protocol optimisation and standardisation:

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

Image quantification and dosimetry:

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

Central Imaging:

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

Comprehensive theranostic technical support:

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.

Rapid clinical trial build

Accelerated patient recruitment

Dedicated support team

Multi-region system integration

Access to unique proprietary real-world data tools

Global standardised quality governance framework

How can we help?

If you are interested in partnering with GenesisCare’s CRO to drive your clinical research, please get in touch today.

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

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Your trusted clinical research partner, every step of the way