Building evidence strategies for new healthcare technologies that align with JCA and HTA expectations from the outset.

• HTA readiness through guideline reviews, scientific advice preparation, and JCA PICO simulations ahead of pivotal trial design.
• Early competitive landscape assessment to support development of a data-driven target product profile (TPP). Using evidence synthesis and indirect treatment comparison methods, we generate comparative insights to inform study design and strengthen product positioning.
• Evidence gap analyses to reduce uncertainty and align value claims with HTA expectations and market access strategy. 
• Advisory boards to gather expert insights and inform evidence generation strategy across key markets. We recruit balanced boards, facilitate focused discussions, and support alignment between stakeholders.

Economic models designed to support pricing strategy, and market access across global and local settings.

• Decision analytic models in Excel and R, including cost-effectiveness and budget impact models, tailored to global and local HTA requirements.
• Pricing analysis to support reimbursement strategy and market access planning across healthcare systems.
• Independent model validation, and technical audit to ensure transparency, robustness and readiness for scrutiny. 
• Early economic modelling to support reimbursement planning, identify value drivers and assess commercial potential.

Evidence synthesis and statistical analysis to generate robust evidence for HTA, pricing, and market access decisions.

• Evidence synthesis using advanced and transparent methods aligned with evolving HTA and regulatory expectations.
• Systematic, targeted and rapid literature reviews, ensuring robust and reproducible methodologies. 
• Indirect treatment comparisons, including NMA and MAIC, to generate comparative effectiveness insights where direct evidence is unavailable. 
• Development of integrated evidence packages aligned with JCA requirements.

Strategic and operational support for reimbursement applications, from global evidence planning through to local adaptation.

• Strategic review of value propositions and supporting evidence to align with local HTA requirements. 
• End-to-end strategic partnership for HTA submissions, from early planning through to post-submission support and local adaptations.
• Preparation of supporting materials including global value dossiers, evidence summaries, and objection handling documents, translating complex evidence into clear and credible value communication.
• Adaptation of global materials to local HTA standards and country-specific requirements while maintaining consistency across markets.
• Submission support including strategic workshops, mock committee meetings and local technical engagement preparation. 

Supporting JCA readiness through proactive evidence planning and coordinated submission preparation.

• Joint Scientific Consultation support to inform evidence strategy and pivotal trial design, ensuring alignment with JCA and EU HTA expectations.  
• Early PICO scoping, simulation, and validation to anticipate JCA requirements, and reduce evidence gaps. 
• Development of robust JCA dossiers, through proactive preparation and targeted updates following PICO confirmation, supporting submission readiness within required timelines. 

Generating decision-ready real-world evidence to support HTA, regulatory, reimbursement, and evidence-generation decisions across global and local settings.

• Data source identification and feasibility assessment, including registries, claims databases, electronic health records, and federated data networks.
• Robust RWE study design, from research question refinement to protocol development and statistical analysis planning.
• Real-world evidence analysis and interpretation, using federated or direct data access routes to address evidence gaps across clinical outcomes, safety, care pathways, resource use, and economic model inputs, with findings translated into decision-ready insights.

Clear and credible communication through scientific publications, training and other commercial materials. 

• Peer-reviewed publications and conference presentations, including posters and manuscripts, translating complex evidence into high-quality scientific communications. 
• Training workshops and educational materials for market access and HEOR teams, covering topics including economic modelling, indirect treatment comparisons, and HTA in Europe and the JCA.
• Development of strategic materials, including white papers, value communication documents, and internal resources to support decision-making and value communication.