Services
End-to-end evidence, engineered to withstand scrutiny.
Our capabilities span the full health technology evidence lifecycle—from early strategy and evidence generation through health technology assessment, reimbursement, defence, and post-launch reassessment.
01
Strategy & planning
Evidence must withstand scrutiny — methodologically, analytically, and contextually.
Evidence strategy & HTA alignment
- Early health technology assessment and reimbursement planning
- Jurisdiction-specific evidence requirements
- Evidence gap assessment and mitigation strategy
- Global value proposition, evidence narrative, and dossier strategy
- Lifecycle evidence and reassessment planning
Clinical & analytical strategy
- Comparator and treatment pathway assessment
- Endpoint and outcome strategy
- External validity and generalizability assessment
- Economic model concept, structure, and assumptions
Uncertainty & stakeholder planning
- Assessment of immature or limited follow-up
- Strategy for indirect or non-randomized evidence
- Planning for small or heterogeneous populations
- Long-term extrapolation and uncertainty assessment
- Clinical, patient, and payer consultation strategy
- Real-world evidence integration planning
02
Evidence generation & synthesis
Evidence is engineered with structural discipline — not retrofitted under scrutiny.
Clinical & comparative evidence
- Systematic literature reviews (SLR) and targeted literature reviews (TLR)
- Meta-analysis and meta-regression
- Network meta-analysis (NMA), including multivariate and survival models
- Multi-level network meta-regression (ML-NMR)
- Population-adjusted indirect comparisons, including matching-adjusted indirect comparisons (MAIC) and simulated treatment comparisons (STC)
- NMA using aggregate-level matching or single-arm evidence
- Surrogate endpoint analysis
- Minimal important difference (MID) and minimal clinically important difference (MCID) estimation
- Post-hoc clinical trial analysis
Economic evidence & value demonstration
- De novo health economic model development, including cost-effectiveness analysis (CEA) and cost-utility analysis (CUA)
- Budget impact analysis (BIA)
- Adaptation of global models to local requirements
- Model conceptualization and structural design
- Incorporation of societal perspectives
- Health state utility strategy
- Cost and healthcare resource use evidence
- Scenario, sensitivity, and uncertainty analyses
Integrated value evidence & global dossier development
- Global value proposition and evidence narrative
- Integration of disease burden, treatment landscape, clinical, humanistic, economic, patient, and unmet-need evidence
- Clear articulation of clinical, economic, and patient value
- Transparent handling of uncertainty and evidence limitations
- Global Value Dossier development and lifecycle updates
- Modular content and evidence packages for regional and local affiliate adaptation
- Consistency across clinical, economic, patient, and broader value evidence
Analytical integrity & governance
- Alignment of clinical and economic assumptions
- Transparent justification of model structures and analytical choices
- Parameter provenance, documentation, and traceability
- Reproducible analytical workflows
- Deterministic and probabilistic validation
- Quality control and technical review
03
HTA submission, review & defence
Evidence must remain coherent — not collapse under interrogation.
Submission architecture & narrative control
- Preparation of jurisdiction-specific HTA and reimbursement dossiers aligned with agency requirements and templates
- Adaptation of Global Value Dossiers and global evidence packages to regional and local decision contexts
- Alignment of clinical, economic, patient, and strategic narratives within the submission
- Consistency between submission claims, supporting analyses, economic models, and source evidence
- Anticipation of likely HTA questions, critiques, and areas of challenge
- Development of submission-ready evidence summaries, appendices, and supporting materials
Technical defence & analytical response
- Structured responses to clinical, statistical, and economic critiques
- Rapid re-analysis, scenario testing, and supplementary analyses
- Review and reconciliation of agency model modifications
- Clarification responses and follow-up submissions
- Technical support throughout iterative review rounds
Negotiation & decision dynamics
- Alignment of the value narrative with payer priorities
- Support through reimbursement recommendation, listing, and negotiation
- Preparation for conditional reimbursement and managed-entry arrangements
- Analytical and evidence support for pricing and access discussions
- Coordination of technical responses with broader reimbursement strategy
04
Post-launch evolution
Reimbursement decisions evolve. So must the evidence.
Evidence evolution & update strategy
- Integration of real-world evidence as it emerges
- Incorporation of mature survival and long-term outcome data
- Structured updates to Global Value Dossiers, economic models, and supporting evidence packages
- Evolution of the global value proposition and evidence narrative as new evidence becomes available
- Proactive evidence refresh aligned with reassessment and market access risk
- Ongoing identification of evidence gaps and future data requirements
Reassessment & policy exposure
- Anticipation of health technology assessment reassessment cycles
- Preparation for conditional reimbursement and managed-entry reviews
- Strategy for reassessment, renegotiation, and future evidence requirements
- Alignment with evolving methodological and evidentiary standards
- Evidence strategy for line extensions, label expansions, and new indications
- Assessment of emerging policy and reimbursement risks
Sustained value & access defence
- Updating economic models using observed utilization and real-world outcomes
- Reinforcing the value narrative as the treatment landscape evolves
- Responding to new comparators, competitive evidence, and changing standards of care
- Preparation for renegotiation, pricing pressure, and revised access conditions
- Coordinated lifecycle evidence and reimbursement strategy across jurisdictions
