Emerald Clinical Trials is a privately held global Contract Research Organisation headquartered in Singapore, with dedicated teams across more than 40 locations spanning Asia-Pacific (Singapore, Australia, New Zealand, Philippines, Malaysia, South Korea, India, Japan, Indonesia, Sri Lanka, Thailand), Europe (including Central and Eastern Europe), the United States, the United Kingdom, and China. The company has operated for over 25 years, serving more than 160 biotechnology companies and 15 of the world’s top 20 pharmaceutical firms, with over 700,000 patients engaged worldwide.

Emerald Clinical’s most distinctive market position is its internationally recognised leadership in renal clinical research — a therapeutic area in which it has conducted over 100 studies across 70-plus countries and assembled a Renal Clinical Development Advisory Board comprising some of the world’s foremost nephrology KOLs, including Professor Jonathan Barratt (IgA nephropathy), Chee Kay Cheung, and Hernán Trimarchi. This renal heritage provides a credibility and site network in nephrology that generalist CROs of equivalent size typically cannot match.

In August 2026, Emerald Clinical completed the acquisition of Hongyi Clinical Development Services, an independent China-based clinical development organisation, meaningfully extending its operational presence and patient recruitment capability within mainland China. The company has also recently received the Asia-Pacific BioPharma Excellence Award (ABEA) for Outstanding Patient Recruitment and Engagement in 2026, reflecting a market-recognised strength in patient enrolment across its Asia-Pacific network.

Key Products and Services

Early Phase Studies

• Phase I clinical pharmacology studies conducted from Australia — an established early-phase development market offering Therapeutic Goods Administration (TGA) regulatory pathway advantages, rapid site activation, and bioavailable treatment-naive patient populations for first-in-human and dose-escalation studies
• Accelerated Oncology Proof-of-Concept programme — a structured early oncology development service combining Phase I/II biomarker-driven study design, Australian early-phase site access, and KOL collaboration to generate rapid proof-of-concept data for oncology sponsors

Clinical Trial Management

• Custom study start-up and design services — protocol development, feasibility assessment, site selection, regulatory strategy, and study optimisation for complex multi-regional trials
• Patient recruitment and retention — high-performance recruitment programmes leveraging Emerald’s Asia-Pacific site network, with a specific recruitment and retention track record recognised by the ABEA 2026 award
• Project management — dedicated project leadership with full sponsor accountability across timelines, budgets, milestones, and risk management
• Clinical trial monitoring — risk-based monitoring incorporating local knowledge across Asia-Pacific and Europe, with a stated track record in data integrity and site performance
• Endpoint adjudication — independent endpoint adjudication committee management and clinical event classification services

Safety and Pharmacovigilance

• Adverse event processing, ICSR management, expedited regulatory reporting, DSUR/PSUR preparation, and post-marketing surveillance support
• Safety database management and signal monitoring across all study phases
• Flexible safety outsourcing models including full pharmacovigilance system management

Regulatory Consulting

• Regulatory strategy and submission support across Asia-Pacific regulatory authorities (TGA, HSA, MFDS, PMDA, CDSCO, NMPA) and global authorities (FDA, EMA, MHRA)
• CTA and IND preparation and management; ethics committee and IRB submission coordination across all covered markets

Medical Writing

• Clinical study protocols, clinical study reports (CSRs), investigator brochures, informed consent forms, regulatory briefing documents, and integrated summaries

Data Management and Biostatistics

• eCRF design, database development, data review, medical coding (MedDRA and WHO Drug), CDISC compliance (SDTM, ADaM), and database lock
• Statistical analysis plans, sample size calculations, interim analyses, and final statistical reporting

Therapeutic Expertise

• Renal — IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), chronic kidney disease, lupus nephritis, and transplant nephrology; anchored by a world-renowned KOL advisory board and the largest renal-specific site network of any CRO globally
• Oncology — solid tumours and haematological malignancies; 106,000+ oncology participants enrolled across 2,200+ sites worldwide; accelerated PoC programme for early oncology development in Australia
• Cardiovascular and Cardiometabolic — cardiovascular outcomes, heart failure, hypertension, lipid disorders, and cardiometabolic indications including obesity

Global Capabilities by Region

Singapore, Philippines, Australia, New Zealand, India, Malaysia, South Korea, Europe, United States, United Kingdom, and China (via Hongyi acquisition); additional reach in Japan, Indonesia, Sri Lanka, Thailand, Central Eastern Europe, and Latin America through partnerships.

Emerald Clinical occupies a clearly differentiated position in the global CRO landscape as the world’s leading renal clinical research organisation — a therapeutic area specialism that provides a durable competitive moat in a segment where KOL relationships, site network depth, and disease-area expertise are the primary determinants of sponsor selection. Its over-100-study renal portfolio across 70-plus countries, combined with a named Renal Clinical Development Advisory Board featuring internationally recognised nephrology authorities, constitutes an accumulated advantage in renal drug development that generalist CROs of comparable or larger size cannot readily replicate. Beyond renal, the company’s oncology franchise — with over 106,000 participants enrolled across 2,200-plus sites — and its early-phase Australia capability through the Accelerated Oncology PoC programme, provide meaningful growth vectors. The August 2026 acquisition of Hongyi Clinical Development Services represents a strategically important step in establishing owned operational capability in China — the world’s fastest-growing clinical trial market — rather than relying on partnerships. Headquartered in Singapore with 40-plus global locations, Emerald Clinical is structurally positioned as the most capable Asia-Pacific-anchored CRO for multi-regional studies that include the APAC region as a core development geography.