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Our expertise

Sydney Clinical Trials Centre
Excellence in Trials. Impact in Health.

  • https://www.sydney.edu.au/medicine-health/industry-and-community/support-us.html Support us
  • https://www.sydney.edu.au/medicine-health/our-research/research-centres/sydney-clinical-trials-centre/our-research.html Our research

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Our research has delivered therapies, informed clinical guidelines, shaped policy and reimbursement decisions, and enabled the adoption of new models of care across diverse therapeutic areas. The data generated through our trials is subject to rigorous review by regulatory authorities and is trusted to support approval and decision-making processes.

Our expertise spans the full trial lifecycle, with integrated capability across trial design, project management, data systems development, quality and safety management, biostatistics, and health economics, underpinned by strong methodological expertise and advanced analytics and translational capability. By bringing together multidisciplinary expertise within a coordinated framework, we provide tailored solutions that meet the needs of each partner, and deliver complex, regulatory–ready, large-scale trials with consistency, efficiency, and precision.

This coordinated approach enables us to go beyond individual studies, supporting platform trials, precision medicine, and large-scale collaborative research programs. Working in close partnership with our collaborators, we provide the expertise and infrastructure required to generate regulatory ready evidence, translate innovation into practice and deliver measurable impact in health outcomes. 

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Global partners and stakeholders

Sydney Clinical Trials Centre (CTC) works through extensive national and international clinical trial networks to deliver studies at scale, connecting partners with diverse populations, leading investigators, and high-performing trial sites across multiple clinical areas. These networks, including disease-specific cooperative trial groups, enable efficient study start-up, strong recruitment pathways, and the delivery of high-quality data across complex, multi-centre trials.

We partner with world-leading pharmaceutical and biotechnology companies, government agencies, health systems, and academic collaborators to advance research that addresses critical health challenges. Our experience in delivering trials aligned to regulatory requirements and approval pathways ensures studies are designed with clear intent for translation into practice, policy, and market access.

By combining deep expertise with established clinical networks, we enable partners to extend reach, accelerate delivery, and achieve meaningful improvements in patient outcomes at scale.

Research design

Better trials begin with better design. Our research design capability helps partners shape studies that are scientifically robust, clinically relevant, and positioned for impact. By combining methodological expertise with practical development insight, we turn complex questions into trial strategies that are feasible, fundable, and ready for delivery.

Better trials begin with better design. Our research design capability helps partners shape studies that are scientifically robust, clinically relevant, and positioned for impact. By combining methodological expertise with practical development insight, we turn complex questions into trial strategies that are feasible, fundable, and ready for delivery.

The quality of a trial is determined early, through the choices made in design, methodology, and analytical strategy. Our methods and design capability supports studies that are efficient, credible, and built to answer complex questions with precision.

We bring together expertise in trial methodology, biostatistics, health economics, and evidence integration to design studies that are fit for purpose and responsive to evolving research needs. This includes adaptive, pragmatic, platform, and other contemporary designs suited to complex therapeutic and policy environments.

By embedding advanced methodological thinking from the outset, we help partners increase trial efficiency, strengthen interpretability, and maximise the value of the evidence generated.

Trials are stronger when they are shaped with the people they are designed to benefit. Our consumer engagement capability helps ensure research is relevant, practical, and responsive to the priorities of patients, carers, and communities.

We support partners to embed consumer perspectives from early design through to implementation and dissemination. This includes input into study design, participant information, outcome selection, and communication strategies.

Meaningful consumer involvement improves feasibility, accessibility, and relevance. It also strengthens recruitment, retention, and the quality of evidence generated, supporting trials that are more inclusive, more credible, and better positioned to improve care.

Successful trials are shaped on expert delivery. Our project management capability provides the coordination, oversight, and governance required to progress studies efficiently from start-up to close-out.

With a team of over 120 trial operations staff, we have the capability and expertise to partner flexibly. We have end-to-end trial delivery capabilities, akin to a Contract Research Organisation (CRO), or can provide targeted support across specific operational functions, depending on partner needs.

We work across complex, multi-site trials involving diverse stakeholders, regulatory environments, and delivery models. Our teams manage timelines, budgets, risk, approvals, vendor relationships, and operational alignment, ensuring studies stay on track and decision-making remains clear.

This structured approach supports delivery at scale while maintaining quality and responsiveness. For partners, it means access to experienced trial leadership that can navigate complexity, align competing requirements, and drive progress with confidence.

Modern trials require digital infrastructure that is secure, scalable, and built for complexity. Our data systems design capability supports the architecture behind efficient trial delivery, high-quality data capture, and reliable oversight.

We develop fit-for-purpose systems for diverse study designs, including contemporary and adaptive models, with capability across electronic data capture, randomisation, workflow design, and system integration. 

Our approach prioritises flexibility, usability, and readiness for oversight and reporting, and can be delivered as part of integrated trial programs or as standalone database development support.

By embedding data strategy early, we help partners reduce friction in delivery, improve data quality, and build the digital foundations needed for efficient execution and high-value analysis.

The reliable evidence generated by Sydney Clinical Trials Centre (CTC) is underpinned by reliable data. Our data management capability ensures clinical trial data is complete, traceable, and ready to support high-quality analysis and decision-making.

We work across the full data lifecycle, from collection strategy and form design through to cleaning, coding, review, and final lock. Strong controls, documentation, and quality processes underpin our approach, supporting consistency across complex and multi-site studies, and can also be applied as standalone data management services for individual studies or programs.

This capability strengthens both trial integrity and operational confidence. For partners, it provides assurance that data is being managed to a high standard, with the rigour needed to support credible analysis, oversight, and downstream use.

Quality is not an add-on to delivery; it is built into every stage of the trial lifecycle. Our quality management and monitoring capability supports studies that are controlled, inspection-ready, and aligned with regulatory, ethical, and scientific expectations.

We apply structured quality systems, risk-based oversight, and targeted monitoring to focus attention where it matters most. This enables proactive issue management, strong governance, and efficient use of resources across diverse delivery environments.

The result is a disciplined and transparent approach that protects participants, strengthens data integrity, and supports confidence in study conduct, particularly in complex or high-stakes trials.

Biospecimen and laboratory capability can expand the value of a trial well beyond its primary endpoints. Our expertise supports translational research that links clinical data with biological insight, helping partners better understand disease, treatment response, and patient stratification.

We support biospecimen strategy, collection, processing, storage, and analysis across a range of trial contexts. Working with specialist collaborators, we help integrate laboratory components that align with study objectives and support future clinical application.

Through collaboration with the Faculty of Medicine and Health, we can bring together biospecimen programs with leading laboratory and translational research expertise, supporting the integration of biological findings with specimen collection, storage, analysis, and clinical interpretation across biomarker science, genomics, pathology, molecular profiling, and precision medicine.

This capability is particularly valuable in biomarker-led and precision medicine studies, where laboratory insight can strengthen interpretation, accelerate development pathways, and increase the strategic value of trial data.

Research delivery

Impact depends on execution. Our research delivery capability brings together the systems, leadership, and specialist functions required to run complex trials with consistency, pace, and control. We work with partners to deliver studies that meet high standards of quality, integrity, and operational performance across diverse settings.

Research evaluation

The value of a trial is realised through the quality of its analysis. Our research evaluation capability combines advanced analytical expertise with strategic insight to generate evidence that informs clinical, policy, reimbursement, and investment decisions.

Biostatistics is central to credible trial design, analysis, and interpretation. Our biostatistics capability supports studies that are methodologically sound, analytically robust, and designed to answer complex questions with confidence.

We contribute from the earliest design stages through to final analysis, with expertise across statistical strategy, endpoints, randomisation, and modern trial methodologies. This includes adaptive, pragmatic, platform, and other advanced approaches suited to increasingly complex research and development environments.

By embedding statistical expertise early, we improve efficiency, reduce avoidable bias, and strengthen the reliability of findings. For partners, this means analysis that supports confident decisions in clinical development, policy, and practice.

Clinical benefit alone is not always enough to drive adoption. Our health economics capability helps partners understand value, supporting decisions about funding, reimbursement, implementation, and scale.

We deliver economic evaluation across the trial lifecycle, from pre-trial modelling and design advice through to within-trial analysis and broader value assessment. Our work considers cost-effectiveness, budget impact, and the wider implications of introducing new interventions into healthcare systems.

By integrating health economics with trial design and analysis, we help ensure evidence is relevant not only to clinicians, but also to payers, policymakers, and health services. This strengthens the case for translation and supports more sustainable uptake of new models of care.

Evidence integration strengthens the value of individual trials by placing findings within a broader research and practice context. Our capability in this space helps partners understand what is already known, where the gaps remain, and how new evidence can drive stronger decisions.

We specialise in systematic reviews, meta-analysis, and broader evidence synthesis approaches that inform guidelines, policy, and future research priorities. This work supports more strategic development pathways, reduces duplication, and improves the overall efficiency of evidence generation.

By integrating data across studies and settings, we help ensure research contributes to cumulative knowledge, not just individual outputs, supporting better decisions and more meaningful change in care.

Health technology assessment (HTA) helps determine whether new interventions are ready for adoption, reimbursement, or broader system use. Our HTA capability supports partners to evaluate clinical value, economic impact, and implementation readiness in a way that informs real decisions.

We bring together evidence synthesis, economic modelling, and policy-facing analysis to support submissions and assessments for government and health system stakeholders. This work helps clarify where a new intervention fits, what value it offers, and how it can be introduced responsibly and sustainably.

For partners, HTA provides an important bridge between evidence generation and system uptake, supporting stronger policy, funding, and implementation outcomes.

ANZCTR

The Australian New Zealand Clinical Trials Registry (ANZCTR)  is a publicly accessible, online registry of clinical trials in Australia and New Zealand. Established in 2005, ANZCTR supports transparent reporting by making key study information available to researchers, clinicians, policymakers, and the community.

As a Primary Registry within the World Health Organization International Clinical Trials Registry Platform, ANZCTR meets international standards for data quality, accessibility, and validity, contributing to a global system that ensures clinical trial information is visible, reliable, and accessible for evidence-based decision-making.

Through its leadership of ANZCTR, CTC plays a key role in strengthening research transparency, supporting trial integrity, and enabling collaboration across the clinical trials community.

Contact us

Mailing address
Sydney Clinical Trials Centre
ABN 15 211 513 464
Locked Bag 77
Camperdown NSW 1450

Physical locations
Lifehouse Building
Level 6, 119-143 Missenden Road
Camperdown NSW 2050

RPA Gloucester House
Level 6, Gloucester House Drive
Camperdown NSW 2050