The launch of Joint Clinical Assessments in 2025 represents a significant change to the marketing authorization process in the EU. It is critical that drug and device developers become informed on the latest guidance to be prepared when this new requirement goes into effect. We can partner with you to develop comprehensive and successful strategies and preparatory activities for different assessment scenarios.
Our experts can help you with:
- PICO definition
- HTA agency and clinical expert early engagement or surveys
- local guideline reviews
- literature reviews
- real-world evidence
- market research
- PICO strategy
- Early engagement
- early scientific advice
- strategy briefing books and process support
- Early value proposition
- optimize value-based price
- early models
- target population
- patient subgroups
- positioning in treatment pathway
- Evidence strategy
- clinical trial design
- patient-relevant endpoints
- payer-relevant endpoints
- control arm selection
- indirect treatment comparison strategy
- synthetic control arms
- real-world evidence
- utility measurement
- Internal stakeholder support
- clinical, regulatory, market access, or in-country collaboration
- company processes and resources
- managing uncertainty
- continuous learning
- workshops
- consulting
- capacity support and staff extenders
- JCA impact assessment
- full portfolio
- therapeutic area
- single asset