Services
From trial design to payer decision — one continuous value case.
Engagements are modular. Start with the question that’s most urgent — an endpoint choice, an HTA submission, a pricing decision — and expand only where the evidence says it matters.
HTA strategy
Build the value story HTA bodies can actually accept.
Map the assessment requirements of each market and shape your development plan so the evidence you generate is the evidence reviewers reward — not the evidence you have to defend.
Scope includes
- HTA landscape & precedent review (NICE, G-BA/IQWiG, HAS, CADTH)
- Submission-readiness gap analysis
- Endpoint & comparator acceptability assessment
- Evidence-generation roadmap to close decision-grade gaps
A market-specific HTA strategy with prioritized evidence actions and clearly stated boundaries.
Market access & reimbursement
Translate clinical strength into access and price.
Position your asset for the payers and pathways that decide uptake — segment discipline, access narrative, and pricing logic grounded in what each system will actually fund.
Scope includes
- Access pathway mapping by market
- Payer value narrative & positioning
- Pricing & reimbursement strategy
- Launch-sequence and access-risk planning
An access blueprint: target segments, payer messaging guardrails, and a sequenced launch view.
HEOR & cost-effectiveness modeling
Models that survive scrutiny, not just spreadsheets.
Cost-effectiveness and budget-impact analysis built to each jurisdiction’s preferred methods and thresholds — transparent assumptions, defensible inputs, decision-relevant outputs.
Scope includes
- Cost-effectiveness & cost-utility models
- Budget-impact analysis
- Threshold & willingness-to-pay benchmarking
- Scenario and sensitivity stress-testing
A validated economic model with a plain-language results readout and assumption log.
Evidence & endpoint strategy
Choose endpoints for acceptance, not just significance.
Endpoint selection and clinical-meaningfulness work that connects trial-design choices to regulatory acceptance and payer value — before the protocol locks.
Scope includes
- Endpoint selection & clinical-meaningfulness review
- Comparator & study-design acceptability
- Evidence-synthesis & indirect-comparison feasibility
- Risk-mitigation for evidence-to-policy gaps
An endpoint & evidence position paper that pre-empts the questions reviewers will ask.
Regulatory & payer alignment
Keep FDA, EMA, and payers pulling in one direction.
Align regulatory and reimbursement strategy so approval and access reinforce each other instead of working against each other across geographies.
Scope includes
- FDA / EMA alignment review
- Global HTA requirement mapping
- Label-to-access translation
- Cross-functional evidence alignment
A reconciled regulatory-and-access plan with explicit decision boundaries.
Comparator & competitive landscape
Know the benchmark that calibrates your payer story.
Comparator profiling and competitive intelligence that separate clinical challenge from access readiness, so positioning stays honest and defensible.
Scope includes
- Comparator evidence inventory
- Competitive access & pricing read-through
- Pipeline & launch-timeline tracking
- Positioning implications & messaging guardrails
A comparator briefing that frames the benchmark without overstating the cross-trial bridge.
07 Who it’s for
Teams who’d rather know the boundary now than discover it at review.
Emerging biotech
Building the evidence and access case for a first or pivotal asset.
Pharma teams
Aligning regulatory and HTA strategy across multiple markets.
Device & diagnostics
Translating clinical utility into reimbursement and coverage.
Investors
Pressure-testing the access thesis behind a diligence decision.
Start an engagement
Not sure which service you need?
That’s exactly what the intake is for. Tell us where your asset is, and we’ll point to the work that moves the access needle first.
~3 minutes · No obligation