PRE-IND Application
- R & D planning
- Protocol development
- Protocol synopsis/summary
- Principal investigator recruitment
- Pre-IND data preparation
- CDE meeting support
IND Application & Preparations
- Protocol development
- RMP writing
- Communications with principal investigators
- Ethics consultation
- Site screening
- Subjects recruitment
- Trial management plan
- Protocol training
- Protocol-related consultation
- Protocol-related consultation and retraining
Study Conduct
- Subject enrollment & treatment
- Site initiation
- Risk-based medical monitoring
- AE reporting and management
- Project audit and QC/QA
- Subject recruitment
- SMO management
- Data management
- Statistical analysis
- Protocol amendments
- CDE communication support
NDA
- Final report writing
- RMP writing
- Preparation of NDA clinical documents
- CDE communication support
Post-marketing Study
- RCT study (conditionally approved for marketing)
- PMS/RWS (added indications)
- Safety-focused monitoring (re-registration)
- Preparation of re-registration documents