Case Study
How a pharma company prepared for EU JCA organizational readiness
Discover how we guided our client to compliance, capability building, and long-term readiness for the EU JCA process
Pharmaceutical companies require a precise understanding of EU Joint Clinical Assessment (JCA) requirements to optimize market access.
A mid-sized pharma company needed help to identify the impact of the EU JCA on its existing organizational structure and launch activities. The objective was to create a comprehensive organizational blueprint for building new capabilities and ensure long-term readiness.
Our team began by developing a detailed process roadmap outlining key steps, requirements, and other considerations to support global, regional, and local teams.
We conducted an in-depth review of the company’s organizational structure as well as its resourcing and existing knowledge on EU JCA. This evaluation uncovered critical gaps and refinement opportunities.
A review of the market access value chain highlighted areas needing updates and strategic adjustments to meet the EU JCA requirements and key milestones. We utilized these insights to create a comprehensive organizational blueprint outlining responsibilities, timelines, and resources necessary to guide and streamline EU JCA preparation activities effectively.
The pharma company updated its organizational structure and launch readiness process with the new resources to ensure EU JCA readiness.
By embedding these requirements into early access, evidence planning, and launch readiness, the company successfully prepared for the EU JCA assessment of its first asset scheduled for 2025.
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