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

Who we are
Who we are
Established in 2019 as an Australian based full-service CRO, we provide tailored clinical development solutions spanning the entire lifecycle of product development, with deep expertise in early phase oncology, radiopharmaceutical and imaging clinical trial requirements. We can leverage our extensive clinical trial expertise to deliver faster, more cost-effective and efficient trials and clinical development support for our customers.
- We have an additional offering of an in-house imaging and dosimetry team (also known as the IRO) that consists of experienced imaging technologists and physicists. Rapid advancement in radiopharmaceuticals development presents notable clinical trial challenges that demand specialized expertise and innovative solutions. As radiopharmaceutical research evolves, the lessons learned and strategies we have employed in our past and current studies will serve as a valuable blueprint for future trials, ensuring that patient safety and data quality remain front and centre.
- As a CRO, we are site and company agnostic, and work routinely with clinical trial sites, academic institutions, and hospital networks. We also work with other local and Global CROs and vendors, providing tailored services to our clients in APAC, USA and South America. With our significant experience in this area of oncology research, we are uniquely positioned to provide tailored support to our clients.
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Our people
Chapter 01
Our Leadership Team

Jovana Milosevic
Head of CRO

Jovana Milosevic
Head of CRO
Jovana joined GC CRO in December 2021, bringing 15 years of experience in clinical operations, business development, and key account management. She has worked with top organizations such as IQVIA, Parexel, George Clinical, and Medtronic. Her expertise covers a wide range of therapeutic areas, including oncology, radiopharmaceuticals, GMOs, gastroenterology, cardiology, coronary and structural heart devices, infectious diseases, and dermatology. Jovana has successfully led clinical trials from First-in-Human to post-marketing phases and has designed tailored data solutions to support post-marketing sales activities.

Head of CRO
Head of CRO
Jovana joined GC CRO in December 2021, bringing 15 years of experience in clinical operations, business development, and key account management. She has worked with top organizations such as IQVIA, Parexel, George Clinical, and Medtronic. Her expertise covers a wide range of therapeutic areas, including oncology, radiopharmaceuticals, GMOs, gastroenterology, cardiology, coronary and structural heart devices, infectious diseases, and dermatology. Jovana has successfully led clinical trials from First-in-Human to post-marketing phases and has designed tailored data solutions to support post-marketing sales activities.

Dr Boon Quan Lee
Director of Physics and Imaging Services

Dr Boon Quan Lee
Director of Physics and Imaging Services
Dr Boon Quan Lee, PhD is the Director of Physics and Imaging Services at GC Clinical CRO heading the in-house imaging Research Organisation (IRO) team. He has over 12 years in nuclear physics and radiopharmaceutical fields. He has led the design and execution of central imaging and dosimetry strategy for diagnostic and therapeutic radiopharmaceuticals in 15+ clinical trials across Ph0-III since 2021. He has supported data interpretation for CSR and biodistribution report writing, as well as regulatory submission post database lock for Sponsors.
He has been a key driver behind the creation of IRO which has evolved into a specialised team of physicists, imaging specialists and physicians offering boutique and innovative imaging and dosimetry solutions to address the unmet needs for growing number of local and international radiopharmaceutical companies. Dr. Lee has also co-authored over 30 publications in peer-reviewed journals.

Director of Physics and Imaging Services
Director of Physics and Imaging Services
Dr Boon Quan Lee, PhD is the Director of Physics and Imaging Services at GC Clinical CRO heading the in-house imaging Research Organisation (IRO) team. He has over 12 years in nuclear physics and radiopharmaceutical fields. He has led the design and execution of central imaging and dosimetry strategy for diagnostic and therapeutic radiopharmaceuticals in 15+ clinical trials across Ph0-III since 2021. He has supported data interpretation for CSR and biodistribution report writing, as well as regulatory submission post database lock for Sponsors.
He has been a key driver behind the creation of IRO which has evolved into a specialised team of physicists, imaging specialists and physicians offering boutique and innovative imaging and dosimetry solutions to address the unmet needs for growing number of local and international radiopharmaceutical companies. Dr. Lee has also co-authored over 30 publications in peer-reviewed journals.

Patrick Foley
Director, Data Operations

Patrick Foley
Director, Data Operations
Patrick has worked in data-management roles of increasing seniority since 2002 with pharmaceutical and biotech companies including Eli Lily, Boehringer, ICON, Aptiv Solutions, Trium Analysis Online and Novotech in Switzerland, UK, Germany and Australia. He is experienced with Veeva, Viedoc, Medidata RAVE, Oracle Inform, Castor and other RTSM/CTMS tools.

Director, Data Operations
Director, Data Operations
Patrick has worked in data-management roles of increasing seniority since 2002 with pharmaceutical and biotech companies including Eli Lily, Boehringer, ICON, Aptiv Solutions, Trium Analysis Online and Novotech in Switzerland, UK, Germany and Australia. He is experienced with Veeva, Viedoc, Medidata RAVE, Oracle Inform, Castor and other RTSM/CTMS tools.

Azmira Khalid
Senior Director, Clinical Operations & Safety

Azmira Khalid
Senior Director, Clinical Operations & Safety
Azmira brings over 15 years of diverse experience in both R&D and the Commercial sectors of the pharmaceutical industry. Within R&D, she has led and managed clinical trial delivery across multiple therapeutic areas and phases, ensuring successful outcomes from early-phase studies through to Phase IV. In the Commercial sector, Azmira has supported market entry of pharmaceutical products and developed tailored data insights solutions to help companies navigate the competitive ANZ market landscape.
Her therapeutic expertise spans key areas such as Oncology, Ophthalmology, Respiratory, Endocrinology, Rare Diseases and Nephrology, with a comprehensive understanding from Phase I to Phase IV studies.
At GenesisCare CRO, Azmira oversees the Clinical Operations & Safety teams, providing leadership in project management and client engagement, ensuring the highest standards of operational excellence and patient safety.

Senior Director, Clinical Operations & Safety
Senior Director, Clinical Operations & Safety
Azmira brings over 15 years of diverse experience in both R&D and the Commercial sectors of the pharmaceutical industry. Within R&D, she has led and managed clinical trial delivery across multiple therapeutic areas and phases, ensuring successful outcomes from early-phase studies through to Phase IV. In the Commercial sector, Azmira has supported market entry of pharmaceutical products and developed tailored data insights solutions to help companies navigate the competitive ANZ market landscape.
Her therapeutic expertise spans key areas such as Oncology, Ophthalmology, Respiratory, Endocrinology, Rare Diseases and Nephrology, with a comprehensive understanding from Phase I to Phase IV studies.
At GenesisCare CRO, Azmira oversees the Clinical Operations & Safety teams, providing leadership in project management and client engagement, ensuring the highest standards of operational excellence and patient safety.

Joseph Su
Associate Director, Project Management

Joseph Su
Associate Director, Project Management
Joseph has over 15 years of clinical research experience, with a primary focus on oncology across Phases I-IV. His therapeutic expertise includes oncology, metabolic diseases, infectious diseases, immunology, nephrology, respiratory conditions, rare diseases, and radiopharmaceutical clinical trial management. He has successfully led multi-country trials in Australia, New Zealand, Korea, Taiwan, Hong Kong, Thailand, and China.
Joseph joined GC CRO in January 2023 and currently leads a team of project managers and project assistants, overseeing various imaging and therapeutic trials and medical device studies in APAC, USA and South America.

Associate Director, Project Management
Associate Director, Project Management
Joseph has over 15 years of clinical research experience, with a primary focus on oncology across Phases I-IV. His therapeutic expertise includes oncology, metabolic diseases, infectious diseases, immunology, nephrology, respiratory conditions, rare diseases, and radiopharmaceutical clinical trial management. He has successfully led multi-country trials in Australia, New Zealand, Korea, Taiwan, Hong Kong, Thailand, and China.
Joseph joined GC CRO in January 2023 and currently leads a team of project managers and project assistants, overseeing various imaging and therapeutic trials and medical device studies in APAC, USA and South America.

Robin Luber
Head of Quality Assurance

Robin Luber
Head of Quality Assurance
Robin brings over 30 years of experience in senior-level quality management roles within the Clinical Research and Pharmaceutical Life Sciences industries. As the Head of Quality Assurance for the CRO at GenesisCare, Robin is responsible for overseeing the design, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with GxP standards and regulatory requirements.
Before joining GenesisCare, Robin served as the Director of Quality at Nucleus Network, an organisation operating three Phase 1 Clinical Research facilities across Australia and the US. During his 14-year tenure, Robin played a pivotal role in developing and refining their QMS, successfully managing multiple Sponsor/CRO audits and regulatory inspections, including those from the FDA and EMA. He also has a rich background in Good Manufacturing Practice (GMP) through his 13 years at CSL Limited, where he began his career in various quality-related positions.
Robin is dedicated to applying Quality by Design (QbD) principles, ensuring that quality is built into every aspect of operations from the outset. He believes in leveraging technology to drive efficiency, improve data integrity, and enhance compliance in GxP-regulated environments. Under his leadership, the Quality Assurance function is seen not just as a compliance requirement but as a strategic partner in improving operational performance and achieving regulatory success.

Head of Quality Assurance
Head of Quality Assurance
Robin brings over 30 years of experience in senior-level quality management roles within the Clinical Research and Pharmaceutical Life Sciences industries. As the Head of Quality Assurance for the CRO at GenesisCare, Robin is responsible for overseeing the design, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with GxP standards and regulatory requirements.
Before joining GenesisCare, Robin served as the Director of Quality at Nucleus Network, an organisation operating three Phase 1 Clinical Research facilities across Australia and the US. During his 14-year tenure, Robin played a pivotal role in developing and refining their QMS, successfully managing multiple Sponsor/CRO audits and regulatory inspections, including those from the FDA and EMA. He also has a rich background in Good Manufacturing Practice (GMP) through his 13 years at CSL Limited, where he began his career in various quality-related positions.
Robin is dedicated to applying Quality by Design (QbD) principles, ensuring that quality is built into every aspect of operations from the outset. He believes in leveraging technology to drive efficiency, improve data integrity, and enhance compliance in GxP-regulated environments. Under his leadership, the Quality Assurance function is seen not just as a compliance requirement but as a strategic partner in improving operational performance and achieving regulatory success.

Krystyn Adolphe
Research Strategy Proposal Developer

Krystyn Adolphe
Research Strategy Proposal Developer
Krystyn joined GenesisCare CRO in December 2021, bringing 17 years of expertise in business development, strategic proposal creation, and budget management for both global and local studies. Prior to GenesisCare, she spent 15 years at IQVIA. With a strong foundation in nursing and a parallel career in clinical research spanning 27 years, Krystyn has extensive experience across all therapeutic areas and phases. Over the past decade, she has specialized in the early phase landscape for ANZ. Her skills in designing strategies and budgets are underpinned by her robust healthcare background.

Research Strategy Proposal Developer
Research Strategy Proposal Developer
Krystyn joined GenesisCare CRO in December 2021, bringing 17 years of expertise in business development, strategic proposal creation, and budget management for both global and local studies. Prior to GenesisCare, she spent 15 years at IQVIA. With a strong foundation in nursing and a parallel career in clinical research spanning 27 years, Krystyn has extensive experience across all therapeutic areas and phases. Over the past decade, she has specialized in the early phase landscape for ANZ. Her skills in designing strategies and budgets are underpinned by her robust healthcare background.
Our services
Chapter 2
Our services
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 completion. We provide a full-spectrum project management solution, encompassing status updates, risk management, vendor coordination, and 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 Support and Imaging Consultancy: Bespoke imaging and dosimetry consultation for protocol development
- Site Imaging Expertise: Site Imaging Manual writing by experienced imaging technologists and physicists, scanner validation and calibration of associated equipment (e.g. dose calibrator and gamma counter), and 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.
- Dosimetry Expertise: Image quantification and dosimetry, Extrapolation of dose from surrogate to therapeutic radionuclides, and Biological equivalent dose (BED) modelling for radiopharmaceuticals.
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, Viedoc EDC, and Medidata RAVE.
- Our approach to clinical trial site management goes beyond the typical CRO model. We prioritize building strong, lasting relationships with trial sites, recognizing the practical challenges they face. By fostering open communication and proactive problem-solving, we help sites overcome potential roadblocks before they arise.
- 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 expertly navigates site selection and works closely with sites to ensure that logistical and regulatory hurdles are addressed, optimizing 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 work with industry standard platform 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 SAE
- 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 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.
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 and medical monitors 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
Our medical monitoring services include:
- Protocol and Investigator brochure development
- Clinical study reports
- Patient Informed Consent writing
- SRC Charter Development and Support
- Medical Monitoring
- CRA Training
- Medical Director Oversight

Our Quality Commitment
At GC CRO, quality is at the heart of everything we do. Our comprehensive Quality Management System (QMS) is designed to uphold the highest standards in clinical research, ensuring participant safety, data integrity, and regulatory compliance across all phases of product development.
Our QMS is built on internationally recognised standards, including:
- ICH GCP E6: Guiding our clinical trial processes to meet the highest ethical and scientific quality standards.
- TransCelerate BioPharma Clinical Quality Management System (CQMS) Framework: Facilitating harmonised processes and risk-based methodologies for enhanced efficiency.
- ISO 9001:2015 Certification: Demonstrating our commitment to continuous improvement and operational excellence.
We proudly adopt the TransCelerate CQMS Framework to align with industry best practices. This commitment ensures faster clinical research processes and more efficient access to treatments for those in need. By embracing these practices, we offer our clients risk-based methodologies and a streamlined approach to clinical development.
Our QMS is managed using the Veeva Vault Quality Suite, which is validated and FDA Part 11 compliant. Key features include:
- QualityDocs: Streamlined management for SOPs and quality documentation, ensuring that all processes are documented and accessible.
- Vault Training: Comprehensive learning management to ensure our team is trained, competent, and ready to meet the highest standards.
This platform integrates seamlessly with Veeva Vault Clinical, providing robust support for our operational activities.
GC CRO has successfully hosted numerous audits from sponsors and certification bodies. Our robust QMS positions us well for regulatory inspections, demonstrating our unwavering readiness and compliance.
Our Quality Assurance team is led by experienced professionals who have guided multiple FDA inspections and international audits. Our team’s global expertise spans across the US, Europe, Chile, and Asia, ensuring that we bring a wealth of knowledge to every project.
Our ISO 9001:2015 certification is a testament to our dedication to operational excellence and quality improvement. This certification underscores our ongoing commitment to delivering high-quality clinical research services that meet the stringent demands of the industry.
News and resources
Chapter 3
News and Resources
- Coming soon
- BIO-Europe Spring, 17–19 March, 2025, Milan, Italy
- ANZSNM, 23-25 May 2025, Melbourne, Australia
- BIO International, 16-19 June, 2025, Boston USA
- SNMMI, 21–24 June, New Orleans, USA
- Coming soon
- Coming soon
Careers
Chapter 4
Careers
- Senior Clinical Research Associate
Alexandria, New South Wales, Australia
Get in touch
Chapter 5
Get in touch
If you are interested in partnering with GC CRO or integrated research network to drive your clinical research, please contact us at clinicalCRO@genesiscare.com
Alternatively, you can complete the below contact form.
Testimonials
Testimonials

Obatica
Specialist clinical trial service provider
As a supplier to GC CRO, Obatica has enjoyed working with their great team. GC CRO displays unmatched unified integration of IRO services. Their studies are always well managed with some of the most experienced and knowledgeable people in the industry. We are happy to recommend GC CRO to any sponsor wanting to perform clinical trials in Australia.
Obatica CEO and Co-Founder

Merigold
Imaging Focused Medical Writing and Scientific Affairs
Working with GC CRO has been an outstanding experience for Merigold LLC. GC CRO's cross-functional operational foundation allows them to meet timelines, adapt quickly to challenges, and their problem-solving capabilities are truly impressive. Throughout our collaboration, the team at GC CRO has been respectful, professional, and always willing to engage in open dialogue, ensuring that the project goals are met efficiently and effectively. Their collaborative spirit and dedication to excellence make them a fantastic partner, and we look forward to continuing our relationship with them.
Principal

Radiopharm Theranostics
Leaders in the development of radiopharmaceutical products
Our ongoing experience in collaborating with GC CRO has confirmed their very strong track record of success across a wide range of services, including project and data management, medical writing and site engagement. The team's therapeutic background, strategic working relationships, deep subject matter expertise and niche trial design capabilities has been an excellent fit for us. We strongly recommend partnership with GC CRO to further advance your goals of optimizing patient care.
VP Medical & Corporate Affairs
Delivering high-quality clinical trial management services specializing in oncology and theranostics, offering innovative solutions through synergistic partnerships
Rapid clinical trial build
Dedicated support team
Australian based resources to maximise R&D tax benefits
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