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, defense, and post-launch reassessment.
Stage 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
- 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
Stage 02
Evidence generation
Evidence is engineered with structural discipline — not retrofitted under scrutiny.
Clinical & comparative evidence
- Systematic and targeted literature reviews
- Evidence synthesis and meta-analysis
- Indirect treatment comparison feasibility assessments
- Network meta-analysis, including Bayesian approaches and multilevel network meta-regression
- Population-adjusted indirect comparisons, including matching-adjusted indirect comparison and simulated treatment comparison
- Meaningful change and meaningful difference analyses, including MID and MCID estimation
- Statistical analysis plans and comparative effectiveness reports
- Targeted post hoc analyses of clinical trial data
Economic evidence & value demonstration
- De novo health economic model development
- Adaptation of global models for local health technology assessment and reimbursement requirements
- Model conceptualization and structural design
- Health state utility strategy
- Cost and healthcare resource use evidence
- Parameter identification and evidence sourcing
- Scenario, sensitivity, and uncertainty analysis
- Value demonstration for health technology assessment and reimbursement
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
Stage 03
Review & defense
Evidence must remain coherent — not collapse under interrogation.
Submission architecture & narrative control
- Dossier development and structuring aligned with agency templates
- Clear articulation of clinical, economic, and patient value
- Transparent handling of uncertainty and evidence limitations
- Consistency across clinical, economic, and strategic narratives
- Anticipation of likely health technology assessment questions and areas of challenge
Technical defense & 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
- Strategy for reassessment, renegotiation, and future evidence requirements
- Positioning for subsequent lifecycle interactions
Stage 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 economic models and evidence packages
- Proactive evidence refresh aligned with reassessment risk
- Ongoing identification of evidence gaps and new data requirements
Reassessment & policy exposure
- Anticipation of health technology assessment reassessment cycles
- Preparation for conditional reimbursement and managed-entry reviews
- 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 defense
- 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
Work with us.
Whether you're planning a first submission or preparing for reassessment, we'd be glad to talk.