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

Work with us.

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