Clinical Development Strategy & Planning
Test the development plan against operational reality before commitments are made.
The challenge
A development plan can look sound on paper and still rest on untested assumptions about timelines, feasibility, budget and vendor capacity. When those assumptions surface during execution, they are expensive to correct.
Scope of support
- Review of clinical development plans and study concepts from an operational perspective
- Protocol and synopsis review for feasibility and operational risk
- Study timeline, budget and resource assumptions
- Outsourcing strategy and CRO or vendor model options
- Preparation of program decision points and governance
Key deliverables
- Operational review of the development plan with prioritized findings
- Integrated study timeline with documented assumptions and critical path
- Outsourcing and vendor model recommendation
- Initial risk register to carry into execution
Expected operational benefits
- Operational constraints become visible earlier
- Assumptions are documented before contracts are signed
- A plan your team and partners can execute against