MENA Clinical Trial Expansion Readiness Checklist

Strategy and feasibility

• Is the regional objective connected to the global development plan?
• Are protocol, population, site, and operational assumptions documented?
• Have local expertise and adviser needs been identified?

Partners and interfaces

• Are CRO, local partner, site, and vendor responsibilities mapped?
• Are qualification inputs and contracting dependencies visible?
• Are global and regional decision rights clear?

Startup and execution

• Is there one integrated dependency and milestone plan?
• Are document, translation, data, supply, and communication flows defined?
• Are time-zone coverage and backup roles established?

Governance and oversight

• Are regional risks included in sponsor-level oversight?
• Are escalation categories and routes agreed?
• Can decisions, actions, and issue closure be reconstructed?

This is an operational planning resource, not jurisdiction-specific legal or regulatory advice.