Strategy & Consulting
Clinical Development Strategy & Consulting
Development plans, regulatory strategy, protocol design and feasibility, worked out before a study starts.
What's Included
- Clinical development plans and target product profiles
- Regulatory strategy and pathway selection (e.g., expedited programs, orphan designation)
- Protocol design, endpoint selection and synopsis development
- Global feasibility across countries and indications
- Gap analysis and due diligence for products, programs and acquisitions
- Risk assessment and mitigation planning
- Scientific and medical advisory, with key opinion leader engagement
- Advisory boards and investigator network building