Your trusted clinical research partner, every step of the way

Unique, full-service CRO, embedded in one of the world’s largest global oncology networks

 

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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:

  1. Access to a large patient population and information on patient availability, for study feasibility & site selection 
  2.  Access to global site network, facilitating improved patient recruitment & retention.
  3. Improved investigator and site engagement - Key opinion leader input into study design & reporting
  4. Access to Real World Data & patient registries 
  5. 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.  

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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

Get in touch:

If you are interested in partnering with GenesisCare’s CRO to drive your clinical research, please contact us today by emailing us, or alternatively, you can complete the below contact form.

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

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