As a boutique consultancy company we have a strong network of experienced consultants who are located in
Australia, China, Europe and the USA. We provide services in clinical development and regulatory affairs to
biopharmaceutical and medical device companies.
Australia, China, Europe and the USA. We provide services in clinical development and regulatory affairs to
biopharmaceutical and medical device companies.
- Advice on clinical development strategy, including protocol and study design
- Project management and clinical monitoring of clinical studies
- Feasibility studies to determine the viability of a clinical project
- Process review to assist our clients to improve clinical study quality, activities also include audit and co-monitoring
- Training, include site training, investigator meeting and in-house training program
- Study set up, including IRB/EC submission, budget development and negotiation, study manual and tool
development
 | Clinical Development | |
| Regulatory Affairs | |
- Regulatory assessment and strategic planning of product development
- Regulatory writings and submissions
- Health authority interactions
- Due Diligence
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