Services
Project Review and Planning
- Review of Project Development Plans
- Resource allocation
- Decision trees - determining go/no-go
- Timeline and milestone development
- Risk management
- Development of back-up strategies
- Feasibility assessments
- Information management to support due diligence and regulatory submissions
- Document preparation for formal project reviews
Non-Clinical Development
- Assist in clinical candidate selection
- Design and implementation of IND-enabling preclinical development programs
- Toxicology, safety pharmacology, PK and ADME
- Drug manufacture planning
- Drug stability studies
- Management of non-clinical studies with CROs
- Site audit and monitoring
- Integration of multidisciplinary studies
- Preparation of submission documents for regulatory agencies
- Preparation of SOPs and Operational Guidelines
Clinical Development
- Early clinical development planning
- Preparation of Investigator's Brochure
- Clinical study design and protocol writing
- Preparation of Study documents
- Audit of CROs and study monitoring
- Trial logistics
- Clinical study oversight and management
- Management of Independent Safety and Advisory Boards
- Preparation of SOPs and Operational Guidelines
- Clinical study report writing