1
Understand the context
Identify objectives, history, constraints, stakeholders and actual pain points.
2
Clarify objectives and constraints
Distinguish what is essential from what is optional, frame the scope and make trade-offs explicit.
3
Structure the operational and regulatory framework
Define responsibilities, documents, flows, milestones, risks and applicable requirements.
4
Secure data and documentation flows
Align science, GDPR, quality, IT, outsourcing and client requirements.
5
Deliver usable outputs
Provide concise, clear, actionable materials adapted to the teams who will use them.
6
Support implementation
Support decision-making, stakeholder discussions and pragmatic execution.