Joint Clinical Assessment
Get Ready for Your 100-Day Sprint
With only 100 days between confirmation of the Population, Intervention, Comparator(s) and Outcomes (PICOs) and dossier submission, companies getting prepared early will be in the best position for EU Joint Clinical Assessment (JCA).
RTI Health Solutions can help you with advance preparation and developing and refining your JCA dossier. As with our comprehensive support in preparation for global HTA, we can work to anticipate likely and appropriate PICOs, prepare the highest quality evidence in advance, and nimbly adjust to the final scope and label changes.
Expertise to Support You Throughout the Joint Clinical Assessment Process
It’s not just knowing what has to be done, it’s having experts that can do it. If you are facing a JCA submission, you want to make sure that you're partnering with a company that has worked extensively in the orphan drug space and can guide you through the entire process.
JCA Strategy and Planning
We can partner with you to develop comprehensive and successful strategies and preparatory activities for different assessment scenarios.
JCA Strategy and Planning Services
From early scientific advice to helping you assess your organizational readiness to developing an evidence strategy, our team offers integrated services to support your JCA preparedness. Let our experts in JCA and rare disease be your trusted partner to develop a strategy for your successful submission.
PICO Prediction
Anticipate how EU Member States will define assessment scope to enable more focused evidence generation, reduced submission risk, and stronger reimbursement positioning
Joint Scientific Consultation
JCA Evidence Generation and Synthesis
For successful JCA submissions, you need compelling and robust evidence to support your product. RTI Health Solutions researchers have deep technical understanding of the JCA methodological guidelines to help generate the required evidence to meet submission requirements. Because of JCA and National HTA interdependencies it is critical to develop a robust evidence generation strategy that meets the needs of all stakeholders.
JCA Evidence Generation and Synthesis Services
Scientific rigor and comprehensive analysis set strong submissions apart. You can rely on our experts to generate the quality evidence you need, including epidemiology and patient-centered research, to create a credible value story that supports your submission.
Integrated Evidence Generation
Long-range planning for improved alignment and efficiency
PICO Prediction
Anticipate how EU Member States will define assessment scope to enable more focused evidence generation, reduced submission risk, and stronger reimbursement positioning