We believe successful drug development requires:
- Thorough early strategic planning
- Intensive oversight of implementation procedures
We act as your development team.
We are not a CRO, but select the best CROs for your project and supervise CROs to help execute your programs.
Project Management
KM can manage entire development including manufacturing, non-clinical program, clinical development, regulatory strategy and patent strategy.
Clinical Study Management
- Based on input from regulatory and clinical experts, KM proposes a development plan
- KM implements the development plan and can manage the clinical development
- We use and supervise CROs to help execute our programs, for example to monitor clinical trials
- For each study KM can
- Draft protocol, CRF, study materials
- Select Sites/CROs
- Organize Steering Committee
- Organize Data Safety Monitoring Board (DSMB)
- Train CROs and sites
- Generate and manage budget and timeline
- Manage
- Monitoring
- Data management
- Drug supply
- Ongoing efficacy/safety data review
- Propose statistical analyses plan
- Generate the final study report