Evidence. Insights. Access.

Evidence strategy for every stage of the product lifecycle.

From first-in-human to loss of exclusivity, MarksMan works alongside Medical Affairs, Market Access, Commercial and BD leaders to decide what evidence each stage demands — anticipating HTA, JCA, CMS and payer expectations — and then to build it.

  1. 01
    Early Development
    TPP stress-testEvidence gaps
  2. 02
    Pre-Launch
    SLR · NMA · ModelsJCA / HTA readiness
  3. 03
    Launch & Access
    Dossiers · AMCPIRA · MFN
  4. 04
    In-Market
    RWE studiesHCP · Patient voice
  5. 05
    Lifecycle & Portfolio
    Expansion · LOEBD due diligence
Where are you in the lifecycle?

Every stage asks a different evidence question. We answer the one in front of you — and anticipate the next.

01Phase I – II

Early Development

Decide what the asset must prove — before the pivotal trial is designed

“Will the planned Phase III endpoints and comparators satisfy HTA and JCA assessors, or only regulators?”

02Phase III – Submission

Pre-Launch

Build the evidence package that survives assessment in every target market

“Which comparators will the JCA PICO scoping and national HTA bodies actually demand?”

03Approval – First 18 months

Launch & Access

Land the dossiers, navigate policy and secure reimbursement market by market

“Will Medicare select this asset for IRA negotiation — and is the evidence package ready if it does?”

04Growth & Defence

In-Market

Generate the real-world evidence and insight that keep the asset winning

“Which real-world questions will payers, regulators and guideline committees ask next — and which data source can credibly answer them?”

05Expansion – LOE – BD

Lifecycle & Portfolio

Extend the asset, defend it at loss of exclusivity and choose the next one wisely

“Which new indications or populations can the existing evidence base credibly support — and which need fresh generation?”

Who we advise

Strategy for the departments that own the evidence

We don't wait for a brief. We work with functional leaders to define the questions worth answering, then bring the multidisciplinary team — physicians, health economists, statisticians, medical writers — to answer them.

Medical Affairs

Prove medical impact, capture field and HCP insights and detect scientific signals early.

Market Access & HEOR

Anticipate HTA and payer expectations — from EU joint clinical assessments to US IRA negotiation, MFN pricing and AMCP dossiers — and build the evidence to meet them.

Commercial & Launch

Read the competitive landscape, understand what drives HCP adoption, and sequence launches with confidence.

Clinical Development & RWE

Design real-world studies whose evidence regulators and payers will accept — and hear the patient voice directly.

Business Development & Licensing

Assess partnering assets through the EU JCA and US payer-value lens before the deal is signed — so licensed science becomes commercial success.

Publications & Biostatistics

Turn data into peer-reviewed evidence — with the analytical rigour and publication strategy that make each paper count.

How we engage

From diagnosis to recommendation — one accountable partner

01

Diagnose

We audit your evidence, competitive and stakeholder landscape against what decision-makers will demand.

02

Strategise

Together we define the value narrative, evidence-generation plan and metrics that prove progress.

03

Generate

Our HEOR, RWE, analytics and medical writing teams deliver the evidence — to HTA-grade standards.

04

Recommend

You receive a strategic report — clear insights, options and recommendations on what your department should do next, and why.

Capabilities

Ten capabilities behind every stage

AI-assisted, consultant-led — where it adds value

Some questions deserve deeper analysis. For those, our consultants draw on in-house AI tools.

Not every project needs them. Where they strengthen a recommendation — an HTA or IRA readiness check, a patient- or HCP-voice analysis, a competitive scenario model — we apply them inside our own workflows. What you receive is the same in every case: a strategic report with clear insights and recommendations.

Thought leadership

We publish what we practise

View all 168 publications

Facing an HTA submission, a launch or an evidence gap?

Start with a 45-minute strategy conversation. We'll tell you candidly what evidence you need — and what you don't.