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Our integrated pathways

Evidence-to-Access Integration Matrix

Where evidence meets execution. We deliver integrated projects that don't just check boxes—they compound impact across regulatory approval, payer acceptance, and clinical adoption.

Discovery & Early Dev
Target ID → IND
Phase I/II Clinical
FIH → PoC
Phase III Clinical
Pivotal Trials
Regulatory Submission
BLA/NDA → Approval
Launch Preparation
P&T → Commercial
Post-Launch Lifecycle
RWE → Expansion
Protocol → Proof of Concept
Clinical Strategy & Evidence
Protocol → Proof of Concept
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Protocol Optimization & Endpoint Strategy
Regulatory endpoint mapping, adaptive trial framework
Time Reduction
Real-Time Evidence Generation
Biomarker integration, patient-reported outcomes
Risk mitigation
Pivotal Trial Evidence Development
Comparative effectiveness data, safety database
Revenue acceleration
Regulatory Decision Support
Risk assessment, advisory committee prep
Competitive advantage
Launch Evidence Foundation
Safety monitoring plan, post-marketing commitments
Revenue acceleration
Real-World Evidence Studies
Registry outcomes research, lifecycle evidence generation
Revenue acceleration
Insights → Decisions
Regulatory Strategy
Insights → Decisions
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Regulatory Roadmap & Scientific Advice
Global regulatory strategy, FDA breakthrough designation
Time Reduction
Development Program Optimization
Protocol amendments, regulatory flexibility
Cost Reduction
Pre-Submission Strategy
Pre-filing meetings, guidance, CMC strategy
Time Reduction
BLA/NDA Submission & Review
Complete submission package, FDA response management
Competitive advantage
Launch Regulatory Support
Label optimization, promotional review, compliance framework
Competitive advantage
Lifecycle Regulatory Management
Label expansion, regulatory maintenance
Revenue acceleration
Science → Clinical Practice
Scientific Engagement
Science → Clinical Practice
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KOL Strategy & Scientific Platform
Advisory board formation, therapeutic roadmap
Competitive advantage
MSL Enablement & Data Dissemination
Scientific communication, treatment algorithms
Competitive advantage
Comparative Evidence Platform
Indirect meta-analysis, comparative effectiveness strategies
Competitive advantage
Medical Information & Publications
Medical information resources, publication
Competitive advantage
Launch Medical Education
Speaker training, clinical practice guidance
Revenue acceleration
Post-Market Medical Strategy
Real-world evidence studies, investigator-sponsored research
Revenue acceleration
Value → Reimbursement
Market Access
Value → Reimbursement
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Value Proposition Development
Payer landscape analysis, value narrative foundation
Cost Reduction
Health Economics Evidence Generation
Economic endpoint integration, budget impact modeling
Cost Reduction
HTA Preparation & Modeling
Cost-effectiveness models, HTA submissions
Revenue acceleration
Payer Engagement & Access Strategy
HTA submission, payer advisory boards
Revenue acceleration
Launch Access Implementation
Formulary positioning, patient access programs
Revenue acceleration
Access Lifecycle Optimization
Real-world value evidence, pricing optimization
Revenue acceleration
Strategy → Approval
Insight Acceleration
Strategy → Approval
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Competitive Intelligence Platform
Pipeline analytics, patent landscape mapping
Competitive advantage
Trial Performance Analytics
Operational metrics, protocol optimization
Time Reduction
Predictive Modeling & AI Insights
Outcome prediction models, ML-driven optimization
Time Reduction
Regulatory Intelligence Dashboard
Submission tracking, approval pathway optimization
Competitive advantage
Commercial Performance Analytics
Launch tracking, market access optimization
Revenue acceleration
Portfolio Strategic Intelligence
Portfolio optimization models, market expansion analysis
Revenue acceleration

Featured Case studies

Integrated Value in Action

Clinical Strategy & Evidence Phase III Clinical

Transforming Rare Disease Market Access Through Strategic Value Communication

Issue

A precision medicine company faced payer resistance for their innovative targeted therapy in a rare hematologic indication. Complex mechanism of action and limited real-world evidence created access barriers despite breakthrough clinical data.

Method

We deployed integrated value communication expertise, combining deep therapeutic knowledge with strategic market access intelligence to create a comprehensive communication ecosystem.

Achievement

Value dossier accepted across key markets

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Phase III Clinical

Accelerating Access Through Regulatory and HTA Alignment Excellence

Issue

A global pharmaceutical leader developing next-generation therapy for rare bleeding disorders needed comprehensive regulatory and HTA landscape intelligence to optimize Phase 3 design and prepare for joint scientific advice.

Method

We integrated regulatory and HTA intelligence capabilities, combining systematic landscape analysis with strategic stakeholder engagement planning to deliver actionable development insights.

Achievement

Comprehensive regulatory and HTA landscape assessment

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Pioneering Patient Impact Through Evidence-Based Research Partnership

Issue

A leading patient advocacy organization identified critical knowledge gaps in post-transplant care for inherited metabolic disorders.

Method

We committed to conducting a comprehensive pro-bono systematic literature review, delivering methodologically rigorous research to advance patient care understanding and clinical practice.

Achievement

First systematic review of acquired metabolic conditions post-transplant

READ CASE STUDY
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Featured Insights

Insights & Perspectives

Insight: Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence
Clinical Strategy & Evidence Regulatory Submission Discovery & Early Dev

Insight: Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence

A brief excerpt about Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence. A brief excerpt about Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence.
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Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence
Market Access Phase III Clinical

Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence

A brief excerpt about Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence. A brief excerpt about Accelerating Global Vaccine Development Through Strategic Medical Affairs Excellence.A brief excerpt about Accelerating Global Vaccine Development Through Strategic Medic…
View Insight →
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Featured publications

Publications

Insight Acceleration Post-Launch Lifecycle

Incidence and Burden of Herpes Zoster in Sweden

Journal: Infect Dis Ther
Authors Södergren E, Mårdberg K, Nishimwe M, et al.

Regional population-based register study examining the incidence and disease burden of herpes zoster across Swedish populations.

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Clinical Strategy & Evidence Insight Acceleration Post-Launch Lifecycle

Global Prevalence of Varicella-Associated Complications

Journal: Infect Dis Ther
Authors Shah HA, Meiwald A, Perera C, et al.

Systematic review and meta-analysis examining the global prevalence of complications associated with varicella infection.

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Market Access Post-Launch Lifecycle

Health Technology Assessment Paradigm in Rare Diseases

Journal: Value in Health
Authors Jain P, Pandey S, Ostawal A

Examines critical determinants shaping HTA frameworks for rare disease therapies and provides strategic recommendations for navigating reimbursement pathways.

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Clinical Strategy & Evidence Market Access Discovery & Early Dev

The Value of Treatment for Infertility

Journal: Best Practice & Research Clinical Obstetrics & Gynaecology
Authors Fenwick E, Eze A, Hooghe T, Pandey S, Chaudhari V, Ostawal A, Luyten J, Harty G

Systematically reviews willingness-to-pay thresholds and methodological approaches for determining cost-effectiveness of fertility therapies.

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Testimonials

  • Working with Arete Access has been an absolute game-changer for our organization. Their team brought a rare combination of deep expertise, strategic thinking, and seamless execution. From the very first call, they understood our challenges and helped us navigate complex regulatory landscapes with clarity and confidence. The quality of their deliverables consistently exceeded expectations—and their ability to adapt and respond quickly made all the difference. We consider them a trusted partner, not just a vendor.

    Smithers — Head of Market Access
    Novienta Pharmaceuticals

  • From early economic modeling to launch support, Arete Access felt like an extension of our team. They bridged science and commercialization with rigor and incredible clarity.

    David Chen — Head of Clinical Development
    HelixPath Pharma

  • Arete Access turned our fragmented evidence into a clear, compelling value story. Their HTA strategy and payer communications shaved months off our market access timeline.

    Anika Mehra — VP Market Access
    Atlas Pharma

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