Global Site Network with Strong Australian Capabilities
Emerald Clinical has cultivated a trusted network of early phase trial sites across Australia, Asia-Pacific, Europe, and North America. Our close collaborations with leading Phase I units, hospitals, and research centers allow us to efficiently recruit participants, whether healthy volunteers or patients with specific conditions.
Australia, in particular, is a key hub for early phase clinical trials, offering:
- Streamlined Regulatory Framework: Australia’s Clinical Trial Notification (CTN) scheme allows for rapid trial initiation without the need for an Investigational New Drug (IND) application, expediting study commencement.
- Financial Incentives: Benefit from the Australian Government’s Research & Development (R&D) Tax Incentive, which can provide up to a 43.5% rebate on eligible clinical trial expenditures, substantially reducing overall costs.
- World-Class Research Infrastructure: Australia boasts a rich research environment with highly experienced investigators and research professionals, coupled with excellent healthcare infrastructure.
- International Recognition: Data from Australian clinical trials are widely accepted by major regulatory bodies, including the FDA and EMA, facilitating global drug development pathways.
By leveraging these advantages, Emerald Clinical helps sponsors accelerate early development programs while ensuring the highest standards of compliance and patient safety.
Unparalleled Reputation in Healthy Volunteer and Patient Studies
Our experience spans a broad range of therapeutic areas, including oncology, neurology, cardiovascular disease, metabolic disorders, and infectious diseases. We have successfully conducted numerous early phase studies in:
- First-in-human (FIH) trials
- Bioavailability and bioequivalence studies
- Pharmacokinetics (PK) and pharmacodynamics (PD) assessments
- Dose-escalation and proof-of-concept trials
Scientific Leadership and KOL Partnerships
Emerald Clinical stands apart from other CROs by integrating scientific leadership and key opinion leader (KOL) partnerships into our clinical research strategy. Our access to renowned investigators, researchers, and therapeutic area experts ensures:
- Innovative trial designs that maximise efficiency and data quality
- Strong site engagement to optimise participant recruitment and retention
- Regulatory and scientific guidance to navigate complex early phase challenges
Our partnerships with leading global researchers and site networks allow us to connect with the best scientific expertise available, enhancing trial success from FIH through early patient studies.
Comprehensive Phase I Services
We offer a one-stop solution for early-phase study conduct across the region, including:
- Medical Writing Services: Development of protocols, Investigator’s Brochures (IB), and Clinical Study Reports (CSR).
- Site Identification and Selection: Access to early-phase capable sites for both healthy volunteers and patient studies.
- Regulatory Coordination: Efficient study implementation and navigation of local regulatory requirements.
- Data Management and Biostatistics: Comprehensive data handling and statistical analysis services.
- Site Management and Monitoring: Dedicated oversight to ensure protocol adherence and data integrity.
- Vendor Collaboration: Established relationships with third-party vendors for laboratory analyses and investigational product management.
- Safety Services: Robust medical monitoring and safety reporting mechanisms.
With a reputation for scientific excellence, regulatory expertise, and operational efficiency, Emerald Clinical is the partner of choice for sponsors seeking high-quality, early phase clinical research solutions.
Partner with Us
If you are looking for a trusted CRO with a proven track record in early phase clinical trials, connect with Emerald Clinical today. Our scientific leadership and operational agility ensure that your Phase 1 studies are conducted with the utmost precision and efficiency. Our global team is ready to support your study’s success, from first-in-human trials to early patient research.
Strategic Leadership in Action
Tamara Murdock
Tamara has over 25 years of clinical research experience in pharmacology and therapeutic areas including oncology, metabolic disorders, cardiology, and dermatology. A distinguished leader in Early Phase, she has worked in a Phase I unit in Australia and with Australian-based CROs. Her expertise and deep passion guide clients to accelerate their early-phase research and transform promising ideas into groundbreaking medical advancements. As Global Head of Early Phase Research, she is dedicated to ensuring that studies are conducted with precision, efficiency, and the highest scientific and ethical standards. Her commitment to excellence and strategic vision make her a trusted partner in bringing new therapies to life.
Case Study
Fast & Flexible Phase I Execution
We provided complete early-phase services for a complex, multicenter Phase I oncology trial in Australia.
Despite intense competition for sites and patients, we:
- Quickly identified and activated qualified, motivated sites through strong local relationships
- Developed an adaptable study design to support cohort expansion and dosing schedule changes
- Completed recruitment ahead of schedule
Our scientific leadership, established site relationships, and early-phase expertise enabled successful, on-time trial delivery in a competitive recruitment landscape.
See our impact in actionFrequently asked questions
What early-phase CRO services do you provide?
We provide comprehensive early-phase CRO services to support every aspect of early clinical development.
Our offerings span medical writing—from protocol development to investigator brochures and CSRs—site selection for both FIH and FIP studies, and regulatory consulting with global and local experts to ensure efficient study implementation and navigation of local regulatory requirements.
We also manage full-service data handling and biostatistical analysis, provide on-the-ground and remote trial site management and monitoring to ensure compliance and data integrity, and offer robust medical monitoring and safety reporting. Explore our Service Overview for more information.
How does your scientific leadership model enhance trial outcomes?
Our scientific leadership model goes beyond traditional advisory roles, with globally recognized experts actively involved in trial design and execution. Their insights help shape innovative, efficient protocols, improve site and participant engagement, and guide regulatory and scientific decision-making throughout the study. This hands-on approach ensures higher-quality data, faster timelines, and more successful early-phase outcomes.
How do you support participant recruitment in early-phase trials?
We use our global site and KOL relationships to identify and activate motivated, high-performing sites. In the U.S., access to proprietary technology allows us to automate site feasibility assessments, accelerating site selection. Using bespoke recruitment strategies tailored to study needs, we help deliver the right participants—whether healthy volunteers or patients—to maximize retention and maintain recruitment momentum. See Patient Recruitment for more information.
How do you ensure compliance with evolving global regulatory standards?
We monitor regulatory changes globally and adapt strategies to maintain compliance. Our dedicated team stays updated on evolving standards, liaises with local authorities, and proactively adjusts documentation, processes, and timelines so you can be confident that your early-phase trial aligns with the latest requirements in every region. See Regulatory Consulting for more information.
Do you provide early-phase services in multiple languages?
Yes, we are a truly global provider of early-phase CRO solutions, providing services and documents in multiple languages. Our local experts ensure that all documents are accurate, culturally appropriate, and compliant with regional regulatory requirements.
Related Services
Study Design & Start-Up
Partner with us to create custom, cost-effective trial strategies that meet regulatory and sponsor requirements, regardless of project complexity.
Patient Recruitment
Accelerate recruitment and boost retention through our established global alliances with trusted sites and investigators, including a strong APAC presence.
Clinical Trial Monitoring
Ensure trial success with expert monitoring and site management, safeguarding data integrity and patient safety through local expertise and oversight.
Safety & Pharmacovigilance
Safeguard patient well-being with expert medical monitoring, real-time pharmacovigilance, and comprehensive risk management strategies across the product lifecycle.