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.
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.
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:
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.
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.
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
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.
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.
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.