What Greenlight Clinical does

Greenlight Clinical is a full-service, physician-led Contract Research Organisation (CRO) headquartered in Sydney, Australia, with a secondary office in Dallas, Texas, and presence across the broader APAC region. Founded in 2015 by Professor Andrew Chang, a vitreoretinal surgeon, the company specializes in early-phase (Phase I–III) clinical trials in ophthalmology, oncology, rare diseases, and gene & cell therapy. Its service portfolio spans eight integrated modules: Clinical Operations, Site Management, Data Management, Biostatistics, Medical Writing, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, with Technical Services unified under one leadership function. The technology stack includes ArisGlobal's LifeSphere Safety platform for pharmacovigilance and Taimei Technology's AI-driven Electronic Data Capture (EDC) solution, combined with CDISC-compliant data management standards and ISO 9001:2015 quality certification.

The company operates a sales-led, direct engagement go-to-market model targeting small and mid-sized biotech, pharmaceutical, and medtech sponsors who require agile, customized trial execution. Pricing is project-based and quote-driven, dependent on therapeutic area, trial phase, scope, and duration, with no public pricing tiers disclosed. Revenue derives from professional service fees across the integrated trial lifecycle. Greenlight Clinical is part of the Acurio Group conglomerate structure and remains privately held, with no disclosed venture capital or private equity investment. The company cites 260+ years of collective team experience and 50+ clinical trials completed in the APAC region, positioning itself as a specialized alternative to large global CROs for sponsors seeking physician-led oversight and Australia's R&D Tax Incentive (up to 43.5%) and fast-track CTN regulatory pathway.

Name

Greenlight Clinical

Legal name

GreenLight Clinical

Website

https://greenlightclinical.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

Greenlight Clinical is a full-service, physician-led Contract Research Organisation (CRO) headquartered in Sydney, Australia, specializing in Phase I-III clinical trials in ophthalmology, oncology, rare diseases, and gene & cell therapy for small and mid-sized biotech and medtech sponsors across APAC and the USA.

Ownership category

akta.pro rank

Product category

Clinical Research Services (Contract Research Organisation)

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research services
• Clinical trial management
• Pharmacovigilance services
• Regulatory affairs consulting
• Biostatistics services

Headquarters

HQ city

Sydney

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Clinical Research Services: Full-service Contract Research Organisation (CRO) providing comprehensive clinical trial services including clinical operations, site management, data management, biostatistics, medical writing, regulatory affairs, pharmacovigilance, and quality assurance. Revenue is generated through service fees for managing clinical trials from Phase I through Phase III, with pricing based on project scope, complexity, and duration.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Greenlight Clinical is a full-service Contract Research Organisation (CRO) that manages clinical trials from Phase I through Phase III for pharmaceutical, biotech, and medtech sponsors. Its integrated service suite covers clinical operations, site management, data management, biostatistics, medical writing, regulatory affairs (TGA and FDA), pharmacovigilance, and quality assurance, with therapeutic specialisation in ophthalmology, oncology, rare diseases, and gene & cell therapy.

Product overview

Greenlight Clinical is a physician-led, full-service clinical Contract Research Organisation (CRO) offering a comprehensive suite of integrated clinical trial services. The company operates a platform-plus-modules architecture with core service modules including Clinical Operations, Site Management, Data Management, Biostatistics, Medical Writing, Regulatory Affairs, Pharmacovigilance, and Quality Assurance. These modules work together cohesively, with Technical Services (Data Management, Biostatistics, Statistical Programming, Medical Writing) managed under unified leadership, and Medical Monitoring integrated within Pharmacovigilance. The company specializes in ophthalmology, oncology, rare diseases, and gene & cell therapy clinical trials, with operations spanning Australia, the USA, and the APAC region.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Operations Comprehensive clinical operations activities for sponsor-led clinical trials, including project management, study feasibility, study start-up, clinical monitoring, study oversight, and execution from study start-up through close-out, delivered to biotech, pharmaceutical, and medtech sponsors.
• Site Management Site management solutions for clinical trials including site network relationships, clinical trial monitoring, site identification, and site oversight services for sponsors across the APAC region.
• Data Management Clinical data management services for sponsors covering database design, data cleaning, quality assurance, CDISC-compliant data standards implementation, safety and adverse event reporting, metadata management, and database lock and freeze coordination.
• Biostatistics Biostatistics and statistical programming services for clinical trials including study design consultation, sample size estimation, randomization schedules, statistical analysis plan development, statistical analyses, and CDISC-compliant dataset development.
• Medical Writing Medical writing services covering regulatory medical writing (clinical study reports, protocols, investigator brochures, informed consent forms) and medical communications (manuscripts, literature reviews, conference presentations, lay language documents) for sponsor clinical development programmes.
• Regulatory Affairs Regulatory affairs services for pharmaceuticals, medical devices, and biologics including TGA and FDA submissions, marketing authorisation support, CTN/CTA pathway assessments, and international regulatory compliance.
• Pharmacovigilance End-to-end pharmacovigilance services including medical monitoring, SAE evaluation, safety signal detection, ICSR management, periodic reporting, safety management plans, and post-marketing support, delivered using the ArisGlobal LifeSphere Safety platform.
• Quality Assurance Quality assurance services for clinical trials, including an ISO 9001:2015 certified quality management system, risk-based monitoring, independent auditing, and ICH GCP compliance.

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Taimei TechnologycoreTechnology or IntegrationGreenLight Clinical has partnered with Taimei Technology to leverage their AI-driven EDC (Electronic Data Capture) solution and platform. This partnership combines Taimei's innovative technology with GreenLight's clinical trial expertise to streamline data management processes and deliver greater value to sponsors, particularly in the APAC region. The collaboration enhances GreenLight's ability to elevate quality and efficiency of clinical trials through integrated digital solutions.
• ArisGlobalcoreTechnology or IntegrationGreenLight Clinical has partnered with ArisGlobal, utilizing their LifeSphere Safety (ArisG) system for pharmacovigilance operations. This best-in-class safety databasing system is customizable per client needs for clinical and post-market drugs, devices, and vaccines, allowing high volume safety processing in-house.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Novotech: Asia-Pacific-focused full-service CRO headquartered in Australia, providing clinical trial services across Phase I-IV with deep regional site relationships. Directly comparable to GLC in APAC geographic focus, therapeutic-area emphasis, and small/mid-biotech customer base, though at significantly larger scale.
• Medpace: Mid-sized full-service CRO specializing in small/mid-sized biotech sponsors with therapeutic-area expertise and a physician/scientist-led operational model. Highly comparable to GLC in target customer segment, agile delivery philosophy, and focus on therapeutic specialization rather than scale.
• Tigermed: China-headquartered full-service CRO with significant APAC presence providing clinical operations, biostatistics, regulatory, and pharmacovigilance services. Comparable in service breadth and APAC focus, though Tigermed has greater scale and deeper Chinese market penetration.
• Worldwide Clinical Trials: Mid-sized full-service CRO with therapeutic-area specialization in CNS, cardiovascular, and rare diseases. Comparable to GLC in mid-market positioning, therapeutic focus, and agile sponsor engagement model.

Broad incumbents

• ICON plc: Top-5 global CRO offering comprehensive Phase I-IV services across all major therapeutic areas including ophthalmology and oncology. Overlaps with GLC's full-service positioning but operates at vastly larger scale with global footprint across all major pharma markets.
• IQVIA: World's largest CRO with technology-driven clinical operations spanning all phases and therapeutic areas. Overlaps GLC's services but offers global infrastructure, proprietary data assets, and integrated technology platforms that GLC partners with third parties to access.
• Parexel: Global full-service CRO providing Phase I-IV clinical development, regulatory, and pharmacovigilance services. Comparable in service offering and therapeutic-area coverage but operates at enterprise pharma scale with significantly broader geographic coverage.
• Charles River Laboratories: Large CRO with strength in early-phase and preclinical research alongside clinical trial services. Overlaps with GLC in early-phase clinical trial delivery and ophthalmology/oncology exposure, though CRD operates at much larger scale and across a broader service portfolio.

Emerging players

• Clinipace Worldwide: Smaller full-service CRO targeting small/mid-sized biotech and specialty pharma with adaptive trial designs and therapeutic expertise. Similar to GLC in customer segment and mid-market positioning, with comparable service scope.
• Pharmaron: China-based CRO/CDMO providing clinical trial services alongside laboratory and manufacturing capabilities. Comparable in APAC orientation and full-service clinical offering, though with integrated discovery-to-manufacturing capabilities GLC does not have.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/greenlightclinical
• Xx.com/GreenLightClin
• Facebookfacebook.com/GreenLightClinical

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Greenlight Clinical