Our experienced Clinical Operations team has a long and successful track record of delivering outstanding results across all phases of clinical research, with the application of this knowledge at the core of our work.
GreenLight Clinical can provide the following key services to your clinical programs, managed in-house with minimal reliance on outsourcing
- Protocol Writing and Development
- Essential Document Development and Management
- RA & HREC/IRB Submissions and Management
- Investigational Product Management
- Clinical Site Monitoring
- Project Management & Site Training
- Laboratory & Third-Party Vendor Management
Our well-established team of expert staff can work with all major electronic data capture (EDC) systems to ensure the seamless recording, delivery and archival of your trial data.
We offer our clients access to first-in-class, internationally recognised systems to fit the specific needs of both your company and your clinical sites.
Our significant investment in cutting edge IT infrastructure means that you can be assured that your trial is progressing on-time and on-budget, with remote access technology breaking down the barriers imposed by physical distance and time-zone differences for international sponsors.
Our flexible delivery model ensures a tailor-made solution that fits your requirements, is fully compliant with international regulators.
Our services include:
- EDC design and Quality Control
- User and Site Administration
- Site EDC Training
- Query Management
- Database Cleaning and Database Lock
- Data Extraction
- Data Post-Processing, Hand-over and Archiving
Our skilled, in-house Biostatistics team is on the cutting edge of trial design, delivering informed, efficient and effective trial designs to clients, along with high-quality study reporting for your clinical programs.
Our core services include
- Study Design
- Statistical Analysis Plan (SAP) Provision
- Randomization Procedure, Integration and Implementation
- CRF Review
- Clinical Data Analysis
- Data Safety Monitoring Board & Safety Committee Support
Pharmacovigilance & Drug Safety
Patient safety is at the core of everything we do at GreenLight Clinical. Our in-house, international pharmacovigilance team ensures the swift, accurate recording and reporting of adverse events for studies conducted across the globe.
Our team uses the first-in-class Oracle ARGUS system to ensure global regulatory compliance, aid faster and more informed safety decisions, and integrate safety and risk-management functions.
We can provide a scaled pharmacovigilance and drug safety solution for clients that is reflexive and responsive to not only the needs of sponsors and investigators, but also to changing international regulatory requirements.
Our core services include
- Patient Safety Event Reporting
- Preparation of Interim Safety Reports
- Patient Safety Data Entry and Management
- Medical Coding of Safety Data
- International Regulatory Advice
Quality Assurance & Training
GreenLight Clinical’s focus on quality assurance and high-quality training to both staff and sites ensures swift and efficient provision of clinical trial deliverables.
Our Quality Assurance team has extensive experience in not only the clinical trials sphere, but also in quality management at Top 5 pharmaceutical companies and clinical trial service providers.
Our QA team also provides advice, consulting and audit services to sites and third-party vendors, at the highest international standard.
- Writing and Implementation of SOPs/WI and general policy
- QA & QC Review and Compliance
- Site and Third-Party Vendor Audits
- Essential Documentation Audits
- System Audits
- QA Training and QMS system development and integration
Medical Affairs & Communications
GreenLight Clinical’s board is unique in that our executive board consists of not only clinical trial professionals, but also successful investigators, pharmaceutical executives and diagnostic experts. Our broad medical experience extends to our operations staff, many of whom are active researchers themselves, holding wide research interests from ophthalmology, haematology, respiratory disease, neurology and dermatology among others.
At the heart of our business is a commitment to the advancing of human health through clinical research. The clear and effective communication of study design and results to both regulators and the wider community is paramount in helping us achieve these goals.
Our Medical Affairs and Communications team is not only geared to the technical aspects of clinical research communication, but also to helping patients understand the results of trials – in the form of lay summaries and fact-sheets in formats appropriate for patients at both the start, and the end of their clinical trial experience.
Our Medical Affairs and Communications Team provides the following services:
- Protocol and Regulatory Submission Writing
- Clinical Study Report Writing
- Participant Informed Consent Development and Writing
- Patient-appropriate Lay Summary Writing
GreenLight offers a unique suite of preclinical models to clients, in a range of indications – both in vivo and in vitro.
We can provide over 150 different validated models of disease, in both GLP and non-GLP settings, across a wide range of indications.
Coupled with state-of-the-art imaging and diagnostics, GreenLight’s integrated preclinical services can accelerate your product from bench to bedside.
Preclinical work conducted in Australia can be eligible for the Australian Government’s 43.5% R&D tax offset on all R&D activities (pre-clinical or human) – putting money back in your hands at a crucial phase of product development.