OUR SERVICES

GreenLight Clinical is a global, full-service CRO. Our company is established and run by a team of highly-regarded physicians and researchers with a multi-disciplinary skill set, and a proven track record in delivering high quality research output to our clients.

Our clinical networks and regulatory expertise are strongly focused on the Asia-Pacific region, with ongoing clinical trials, research collaborations and contact with key opinion leaders extending worldwide.

Our staff of experienced, knowledgeable clinical trial professionals aims to provide the highest quality research outcomes for our partners, and as a full-service provider, our teams cover all aspects of clinical trial management, drug & device development and global regulatory affairs.

Coupled with our suite of clinical trial services, GreenLight’s Central Laboratory can save our clients time and money by seamlessly integrating safety pathology and specialist testing under the one contract, eliminating numerous pass-through costs and overheads that may be seen with external providers.

     Preclinical

Unique to the global CRO space – GreenLight offers an expansive suite of preclinical models to clients, in a range of indications – both in vivo and in vitro. With our institutional partners – we can provide over 150 different validated models of disease, in both GLP and non-GLP settings.

Coupled with state-of-the-art imaging and diagnostics, GreenLight’s integrated preclinical services accelerate product from bench to bedside.

At GreenLight Clinical we have the research experience and regulatory knowledge to ensure rapid start up, efficient conduct and high-quality outputs from early phase studies that, in turn, support broader, global commercialisation.

With its internationally recognised research capabilities, clinical infrastructure and highly skilled researchers, Australia has all the prerequisites for successful early phase trials. Added to these factors, a stable socioeconomic environment, and top 10 ranking for ease of doing business and its proximity and access to Asia, its clear to see why the numbers of early phase clinical trials in Australia increase year on year.

For those seeking to onduct early phase studies in Australia, a host of government-supported policies and processes has enabled cost reductions and increased regulatory speed and flexibility, without sacrificing clinical trial quality.

Australia has an informed and willing population of potential trial participants, resulting in a higher level of research participation than would be expected from a population of our size. Australia is a multicultural country with a diverse population that is capable of meeting recruitment needs. The ready transfer of data for approval submissions in significant markets – including acceptance by the US FDA and the European EMA – opens up a broader, streamlined commercialisation pathway for sponsors. Most importantly, a 41% tax incentive (where 41% of all your spend on clinical trials can be refunded to you each year) is available to sponsors, along with an attractive exchange rate against global currencies, where per-patient costs can be reduced up to 60% compared with studies in the United States and Europe.

GreenLight Clinical Leveraging Site Networks, Research Skills & Proprietary Technology.
Complementing the benefits of our location, GreenLight Clinical brings its own strengths to offer our clients optimal outcomes from early stage evaluation. These include:

  • Researchers with a background in academic and preclinical research as well as physician investigators
  • A solid network of Phase I sites and experienced personnel
  • Presence in key Asian and European markets, including China, Taiwan, Thailand, Korea and Denmark
  • Proprietary in-house technologies, including internet-based geo-targeting of subjects for rapid, efficient and affordable trial recruitment

     Early Phase

     Clinical Operations

A knowledgeable, organised and well-resourced approach is critical for the efficient running of clinical trials. At GreenLight Clinical, our Clinical Operations team comprises individuals who have managed a multitude of studies, from small, highly-focused investigations to multinational pivotal trials. Our core of physician researchers and scientists bring a further hands-on dimension, while our technology and resource experts ensure the best tools are available to run studies, maintain standards and compliance, and achieve regulatory approval.

GreenLight’s Clinical Operations division emphasises on flexible, innovative strategies and trial management aimed at driving outcomes. Key features include:

  • Expansive clinical capabilities, across therapeutic fields and preclinical-clinical phases
  • Thorough knowledge of clinical/health/regulatory systems in various markets
  • Expertise in ICH/GCP compliance and international standards
  • Implementation of advanced technology solutions, including geo-targeted, internet-based patient recruitment
  • Personal physician networks for wide-ranging access to sites and patient databases
  • A solid record of key performance metrics

Efficient, well integrated and flexible data management is recognised as a key factor in the overall safety, success and timeliness of clinical trials.

The GreenLight Clinical Data Management Division is experienced with a range of validated data systems and has the expertise to incorporate cutting-edge methods and technologies. With a solid foundation in the IT and pharmaceutical industries, our team has worked on global trials, meeting the challenge of complex studies conducted to internationally-recognised standards. For our partners, this translates to the able assessment of study-specific requirements and the implementation of tailored solutions using multiple software applications.

Clinical Data Management is a central service offering from GreenLight Clinical, supported by industry-standard systems and our own proprietary technology to enable reliable, safe and regulatory compliant data collection from clinical studies. With a focus on solutions development and stringent quality assurance measures we deliver core services in study design, case report form (CRF/eCRF) design, data collection, data management and reporting.

     Data Management

     Biostatistics

Statistically-sound studies and adequately powered data are integral to the development program of any investigational entity, allowing the considered planning of clinical studies and forming the basis of regulatory submissions.

Our experienced Biostatistics Division provides core, data-driven guidance for optimal study design and the thorough analyses of clinical and pharmacokinetic/pharmacodynamic studies. Our key personnel each have 20-plus years experience working on landmark global clinical trials and this expertise enables us to deliver reliable study design, protocol development and planning solutions, as well as the meaningful analysis and reporting of outcomes.

Working closely with our data management team, the Biostatistics group is supported by internationally -recognised, best-in-class IT systems and all statistical analyses are undertaken with programmed reproducible methods using industry standard software packages. Together with a secure, dependable and fully backed -up computing environment, our team is expert in targeting and optimising data collection and analysis.

At GreenLight Clinical, we provide an integrated biostatistics analysis package comprising a full range of services that help our clients meet the objectives of their product development program. Covering all study types, from preclinical through Phases I-IV, we offer flexible, tailored options.

Our dedicated Regulatory Affairs team provides advice and services to the pharmaceutical and healthcare industries within Australia and around the world. Comprising professionals who have similar roles in large, multinational companies, we can assist you to secure registration of the following:

  • Prescription medicines – including solid, injectable and topical dosage forms, and other specialised delivery types (e.g. ophthalmic, respiratory products)
  • OTC medicines
  • Complementary medicines
  • Nutraceuticals and health supplements

The requirements for commercial registration – from technical documentation through reimbursement and on to post-marketing information – necessitates a wealth of experts. GreenLight Clinical can undertake the necessary diligence to advise and/or help with:

  • Preparation of all pre-and post-approval submissions
  • Literature-based submissions
  • Identification of data requirements for key markets
  • Technical documentation and scientific justifications (process and validation reports, pharmaceutical development reports, stability monitoring/trending etc.)
  • Health Authority pre-submission meetings
  • Project management
  • Reimbursement
  • Agency representation & non-commercial sponsorship
  • Product sponsorship transfers
  • Artwork, PI and CMI management
  • Dossier management
  • Full Regulatory Information Systems management

Alternative approval pathways offer a significant opportunity.
Our team can help evaluate and develop such specialised submissions, including:

  • Special access scheme applications
  • Orphan drug designations
  • Fixed-dose combination applications

     Regulatory Affairs

     Pharmacovigilance

Experience in Risk Management Planning, SAE Monitoring, Timely Reporting The goal of safety monitoring is to identify, evaluate, minimise and appropriately manage product -related risk. At GreenLight Clinical, our experienced Drug Safety & Pharmacovigilance team understands how the safety profile of a product critically impacts on its development and ultimately , the regulatory approval process and beyond. We employ procedures that pick up early safety indicators and which prompt targeted safety evaluations across all product development stages. This timely response is both beneficial for patient safety and allows a critical assessment of a product’s potential at an early phase of development, potentially saving on costs.

Our Drug Safety & Pharmacovigilance division emphasises proven strategies for safety monitoring that rapidly establish risk/benefit balance and allows informed risk management planning. Key features include:

  • Systematic, patient-centred & active safety surveillance
  • Expansive regulatory understanding across key global markets
  • Expertise in ICH/GCP compliance & international standards
  • Implementation of advanced technology solutions for adverse event reporting and auditing
  • Timely communication of safety findings across multiple study sites and to all stakeholders

GreenLight Clinical’s Medical Affairs department is a vital link between the scientific and clinical arms of product development, with our team of skilled experts providing incisive, high-quality communications and documentation at all stages of the clinical trial lifecycle – along with constant interaction with investigators and key opinion leaders to ensure timely enrolment for your study.

We provide the full-spectrum of medical communications services – from study design, protocol and essential document writing – to regulatory submissions, clinical study reports and academic publication support to sponsors.

Further – our team is tightly integrated with leading principal investigators and key opinion leaders across a wide range of therapeutic areas, ensuring your study is on the cutting edge of trial design and that your decisions are informed by real-world data.

This contact with the best minds in the field drives our commitment to improving clinical outcomes for patients, and their feedback is delivered to you by a dedicated Medical Science Liasion team, keeping you informed at every stage of product development.


Medical Affairs
& Communications

     Quality Assurance

Quality Assurance in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data and thereby assures internal consistency.

At GreenLight Clinical we have dedicated, highly qualified quality assurance professionals with a deep knowledge of regulatory guidelines and legislation and experience in conducting standalone audit services.

The scope of audits that can be conducted include investigator site audits and vendor/ supplier audits.

GreenLight Clinical offers independent QA services by highly experienced professionals, across all clinical trial phases.

As well as being an integral part of our internal processes, GreenLight Clinical is able to provide a full range of independent Quality Assurance services from pre-clinical, through phase I to phase IV studies.

Available internationally, GreenLight Clinical’s clinical trial audit ensures high ethical standards of clinical trials are upheld and minimises risk to data integrity.

Our QA department is staffed by experienced professionals who operate independently from the personnel engaged in the management and conduct of clinical trials.

Quality Assurance services encompass all aspects of the clinical development process, including:

  • Trial Master File Audits Investigator Site Audits
  • Phase I Units Systems Audits
  • Third party vendors including archive facilities, Investigational Product management and other
  • CROs Study Documentation e.g. Protocols, Clinical Study Reports
  • Computer system validation reviews local, central and bioanalytical laboratories
  • Database Audits GLP Audits
  • Bioanalytical method validation quality system management
  • Due diligence