Emerald Clinical

Emerald Clinical offers comprehensive early phase oncology clinical trial services including study design, protocol development, project management, medical oversight, feasibility, pharmacovigilance, site management and monitoring, regulatory affairs, statistics, and data management.

Regulatory consulting services to accelerate market path with local expertise, ensuring compliance, minimizing risks, and driving faster approvals for clinical trials.

Emerald Clinical accelerates oncology Proof-of-Concept programmes through a uniquely integrated early-phase model spanning the USA, Europe, Australia, and China, helping biotechs and pharmas achieve faster first-patient-in, earlier readouts, and reduced development risk for targeted and advanced oncology therapies.

Comprehensive biostatistics including consulting, study design development, interim analyses, and support for DSMC and IDMC meetings with programming of statistical outputs such as SDTM, ADaM, and TLFs.

Secure, integrated data management solutions and expert biostatistics services for maximum insights and impact.

Accurate documentation services from protocol development to statistical reports and regulatory submission to drive efficient approvals.

Comprehensive patient recruitment services combining site and investigator relationships with a patient-focused approach to connect with the participants needed for clinical trials.

Emerald Clinical's Scientific Leadership services provide expert leadership and coordination for clinical trials, enhancing recruitment, retention, and study cohesion, especially in challenging conditions such as the COVID pandemic.

Dedicated project management services providing focused attention to clinical studies, backed by experienced teams, flexible solutions, and clear communication to keep studies on track, on budget, and delivering results.

Streamline your clinical endpoint adjudication process with confidence through global insights, advanced paperless systems, and efficient workflows. Provides medical expertise with operational excellence to generate reliable, unbiased data and guide studies to milestones.

Emerald Clinical Trials Asia Pacific offers clinical research organization services in Malaysia, leveraging the country's multi-ethnic population, established healthcare systems, and government support for clinical trials.

A specialized team managing the review and adjudication of clinical endpoints, particularly cardiovascular and renal, across a range of trials from smaller outcomes to large, global, registration studies.

Regulatory-ready clinical study reports (CSRs) developed to meet ICH E3 guidelines, support publication, and deliver actionable insights for stakeholders.

Comprehensive safety oversight throughout clinical trials and beyond, including medical monitoring and real-time pharmacovigilance across the product lifecycle to protect patient well-being and ensure compliance.

Protocols designed to minimize delays, maximize compliance, and ensure reliable outcomes with input from patients and integration of clinical practice ideals.

Reports providing robust analyses and visual data representation to support regulatory success and informed decision-making.

A customized dashboard for tracking queries and backlogs in clinical data management.

A strategic advisory board designed to help sponsors make smarter, faster, and more patient-centered decisions in renal drug development, focusing on IgA nephropathy, chronic kidney disease, and glomerular diseases.