Excellence in Early Phase Clinical Research

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.

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.