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.
How we can help you
Strategy and Planning
- Early PICO simulation & PICO strategy
- Early external stakeholder mapping
- Value proposition planning
- Integrated evidence planning
- Internal stakeholder workshops & training
- Portfolio JCA impact assessment
- Organizational readiness
- JSC submissions
Evidence Preparation
- PICO validation and prioritization (AI assisted)
- JCA statistical analysis plan development
- JCA dossiers
- Clinical systematic literature reviews (including 3-month window updates)
- Indirect treatment comparisons
- External comparator studies
- External stakeholder engagement
Ongoing Support
- Clarification questions
- Factual accuracy checks
- Objection handling for non-submitted PICOs
- Post-submission support
- Support for individual country HTAs
Offerings
Health Economics
RTI-HS delivers health economics consulting solutions to demonstrate product value, support HTA submissions, and inform market access decisions.
Health Economics Services
As one of the most experienced and respected health economics consulting and research organizations, we can provide strategic advice and help you choose and implement the right methodology to answer your research questions. We also provide innovative methods to uncover hidden subpopulations or differential responders in your data that can lead to new opportunities for your product.
Decision-Analytic Models
Database Studies
Leverage databases for health economic and pharmacoepidemiology research, enhancing safety assessments, and treatment effectiveness studies
Utility Assessment
Measure patient preferences for health outcomes to generate utility scores for use in your economic models to inform decisions on healthcare resource allocation and product value
Literature Reviews
Synthesize existing scientific findings to help you evaluate current knowledge, identify gaps, and inform development decisions
Meta-Analysis
Use rigorous, state-of-the-art methodologies to quantitatively synthesize evidence from literature reviews and enable reliable insights for healthcare decision-making
ICER Support
Proactively protect value, optimize pricing, and ensure your therapy aligns with ICER’s evolving landscape
Workshop / Training
Invest in learning that delivers lasting impact with our blend of expert insights and practical tools to help your team thrive in a continually evolving landscape.
Delphi Panels
Retrospective Chart Reviews
Cross-Sectional Surveys
Capture current disease prevalence, treatment modalities, and risk factors to enrich your real-world evidence for dossiers and support regulatory applications
Longitudinal Surveys
Leverage the power of longitudinal studes to understand changes in health, treatment response, and real-world outcomes over time
Statistical Analysis
Data analysis and visualization that can help strengthen your pharma or medical technology product development
Causal Inference
Clinical Trial Data Analysis
Unlock the full potential of your clinical trial data by transforming complex datasets into clear, compelling insights that drive regulatory success and market access
Site-Based Studies
Combine the rigor of in-person clinical assessments with deep patient insights gathered through structured surveys
External Control Arm Analysis
Use real-world evidence to efficiently and credibly evaluate novel treatments
Value and Access
You need the right strategies and tactics to reflect your product’s value and gain market access. And when millions—or maybe billions—are on the line, you have to be confident that your healthcare market access strategies are well researched and that your tactics reflect real-world context. We can partner with you to deliver the research quality and integrated thinking your drug, diagnostic, or device needs to achieve optimal market access. Our experience spans all major therapeutic areas and phases of development.
Value and Access Services
At every stage of your product’s lifecycle, we can help you develop a strategic roadmap to effectively demonstrate and communicate your product’s value. For clinical and commercial teams alike, we provide extensive research experience, industry and regulatory knowledge, and evidence-based tools to help commercialize your product.
Value Communication Materials
Ensure your research findings and value messages can be adopted by relevant audiences with high-impact communication tools
Expert Perspective Research
Global Value Dossiers
Comprehensive, evidence-based deliverables that communicate the clinical, humanistic, and economic value of your product to diverse stakeholders
AMCP Dossiers
Standardized AMCP dossiers present evidence of your product’s value to support formulary decisions by U.S. healthcare payers
Delphi Panels
Literature Reviews
Synthesize existing scientific findings to help you evaluate current knowledge, identify gaps, and inform development decisions
HTA Submissions
Strategic and technical expertise to help you develop and submit high-quality health technology assessment (HTA) and reimbursement dossiers for global market access.
Related JCA Resources
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