Comprehensive Clinical Research Organization Services – Australia and beyond
Clinical research is critical in achieving risk mitigating milestones by demonstrating safety and/or efficacy parameters for medical products.
We leverage our experience in the commercialization of medical technologies to provide the support needed to early stage clinical studies.
What we provide
- Overall management of trials on behalf of International Sponsors from start-up to close-out
- Identification and access to key opinion leaders
- Clinical investigational planning and trials/study design in accordance with international guidance documents
- Assistance with the development of the essential trial dossier
- Application to Ethics (IRB) committees and regulatory bodies
- Contract negotiation
- Training, monitoring and verification