Unique, full-service oncology focused CRO with a fully integrated Dosimetry and Imaging Core lab

We offer comprehensive project management for clinical studies, ensuring operational excellence while safeguarding patient safety and data quality. Our expert project managers serve as your central point of contact, seamlessly integrating with your team from initiation through to completion.

We provide a full-spectrum project management solution, encompassing:

• Status updates
• Risk management
• Vendor coordination
• Milestone tracking

All tailored to meet your specific needs.

GC CRO has an in-house imaging and dosimetry core lab (IRO), specialising in the provision of comprehensive radiopharmaceutical dosimetry and central imaging services to support oncology and radiopharmaceuticals research.

Our IRO services include full-service central imaging, dosimetry analysis, and imaging endpoints consultancy for drug development.

Protocol development and imaging consultancy

• Bespoke imaging and dosimetry consultation to support protocol development

Site imaging expertise

• Imaging Manual development by experienced imaging technologists and physicists
• Scanner validation and calibration of associated equipment (e.g. dose calibrator and gamma counter)
• Streamlined image receipt, QC, and query resolution
• Blinded Independent Central Reviews: Reader selection and training and Image Review Charter Writing, Blinded central eligibility and efficacy reads. Central image review across all imaging modalities, including but not limited to PET, SPECT, CT, MRI.
  

Blinded independent central reviews

• Reader selection and training, and Image Review Charter development
• Blinded central eligibility and efficacy reads
• Central image review across all imaging modalities, including PET, SPECT, CT, and MRI

Dosimetry expertise

• Image quantification and dosimetry
• Extrapolation of dose from surrogate to therapeutic radionuclides
• Biological equivalent dose (BED) modelling for radiopharmaceuticals

Accurate and reliable clinical data is essential to assessing whether a study’s primary and secondary endpoints have been achieved, and is a key component of any application for regulatory approval.

We aim to remove data management from the critical path through an innovative and agile approach that adapts to different protocol complexities.

We work with industry-standard electronic data capture (EDC) platforms, including Veeva EDC, Viedoc EDC, and Medidata Rave.

strong, lasting relationships with trial sites, recognising the practical challenges they face. By fostering open communication and proactive problem-solving, we help sites overcome potential roadblocks early.

With extensive experience in radiopharmaceutical trials, we understand the specific operational challenges associated with these studies, including the impact of site location, capabilities, and the complexities of radiopharmaceutical IP delivery. Our team supports site selection and works closely with sites to ensure that logistical and regulatory hurdles are addressed, optimising trial performance and patient safety.

At GC CRO, our dedicated team of pharmacovigilance (PV) experts ensures the safety and well-being of patients while guiding our clients through every phase of product development. With a deep understanding of the complexities involved, we provide comprehensive PV solutions tailored to support the unique demands of each stage of your clinical program.

Our PV team works with industry-standard platforms to manage case reporting.

Our PV services for Phase I–IV development include:

• SAE case processing and management
• SAE narrative writing
• Medical monitor review of SAEs
• Safety report distribution and submission to regulatory authorities

GC CRO partners with leading biostatistics service providers based in Australia, who work in close collaboration with our data management and project management teams throughout all stages of a study.

Our services include:

• Sample size estimation and methodology review
• Statistical analysis
• Rapid data delivery
• Access to compatible data formats and files
• Clinical study report delivery

We offer end-to-end clinical research communication services, supported by a comprehensive understanding of in-country regulatory requirements and scientific communication expertise.

Our medical writers and medical monitors work closely with 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 document development
• Publications and abstracts
• Investigator education materials

Our medical monitoring services include:

• Protocol and Investigator’s Brochure development
• Clinical study reports
• Patient informed consent development
• SRC charter development and support
• Medical monitoring
• CRA training
• Medical Director oversight 

At GenesisCare CRO, quality is embedded in how we work, how we deliver, and how we support our clients. Our Quality Management System is designed to protect participant safety, support data integrity, and maintain regulatory compliance across the services we provide.

Quality is owned across the organisation, with operational teams responsible for delivering it day to day and our dedicated Quality Assurance function providing independent oversight. This structured approach helps ensure that quality is built into our processes from the outset and consistently maintained throughout service delivery.

Our Quality Management System is built on internationally recognised standards and industry best practice, including:

• ICH GCP E6, which guides our clinical research processes to support participant safety, ethical conduct, and scientifically sound data
• The TransCelerate BioPharma Clinical Quality Management System framework, which supports a harmonised and risk-based approach to quality management across clinical research activities
• ISO 9001:2015 certification, providing independent external confirmation that our Quality Management System is established, maintained, and focused on continuous improvement

Together, these foundations support a structured and scalable quality environment designed to meet the expectations of sponsors, regulators, and other stakeholders.

We apply Quality by Design principles and proportionate risk management to build quality into our services from the outset, rather than relying on retrospective correction. This means considering critical processes, risks, controls, and responsibilities early, so that the right foundations are in place before issues arise.

Our approach is designed to focus effort where it matters most to participant safety, data integrity, and reliable service delivery. By taking a proactive and risk-based approach, we support more consistent execution, clearer oversight, and stronger operational control across our clinical research activities.

Our Quality Management System is supported by Veeva Vault Quality, which provides a controlled digital environment for managing key quality processes and documentation. This supports consistency, oversight, traceability, and efficient access to current information across the organisation.

Key capabilities include:

• Document management to support controlled SOPs, policies, work instructions, forms, and related quality records
• Training management to support role-based learning, training assignments, and evidence of staff competence
• Structured workflows to support review, approval, change control, and other governed quality activities

This platform also supports broader quality processes such as CAPA, vendor assurance, audit management, and training oversight, helping ensure our quality framework is embedded in day-to-day operations rather than managed through disconnected manual systems.

Our Quality Management System is designed to support audit and inspection readiness across the organisation. We have successfully hosted sponsor audits and external certification audits, and our structured quality framework supports a state of operational readiness for regulatory inspection.

This includes controlled documentation, defined processes, training oversight, change management, CAPA, vendor assurance, and ongoing quality review. Together, these elements help ensure that we can demonstrate not only that the right processes exist, but that they are implemented, maintained, and supported in practice.

Our Quality Assurance function is led by experienced quality professionals with deep expertise across clinical research and regulated environments. This experience supports the development, oversight, and continuous improvement of our Quality Management System and helps ensure quality remains aligned with both regulatory expectations and operational needs.

More broadly, quality is supported across the organisation through defined processes, structured training, and clear accountability. This helps create a quality culture in which teams understand their responsibilities and are equipped to deliver services in a consistent, compliant, and reliable manner.

Our ISO 9001:2015 certification reflects our commitment to maintaining a structured and effective Quality Management System. It provides independent assurance that our quality framework is regularly assessed against a recognised international standard and supports a culture of governance, consistency, and continuous improvement.

We see quality as more than compliance alone. It is a core part of how we strengthen our services, improve our systems, and give sponsors confidence that the right controls, oversight, and quality foundations are in place.