Services - investigator support
We can assist with advances in scientific knowledge using clinical research, such as conducting investigations using Evidence-based medicine(EBM) especially with investigator-initiated studies. With our various investigator support experiences, we have built a broad Japanese investigator network that is highly competent in the field of clinical research.
- Consulting services
- Project management for clinical studies
- Regulatory support
- Research organization management consulting
- Operating service
- SOP preparation support
- Document preparation suach as Protocol, IB, CRF and Informed consent material
- Regulatory support (GCP Compliance Review, Safety Information Report)
- Coordination with IND supplier
- Risk-based monitoring planning and support (Central monitoring, Targeted monitoring, SDV sampling)
- Training (GCP training, CRA training, on the job training, etc.)