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Delivering integrated impact

Riding the Wave of Healthcare Innovation

In healthcare innovation, patient access comes from integrated thinking and rigorous execution across clinical, regulatory, and market access.
About Us

Integrated Excellence. Accelerated Outcomes.

Arete Access helps life science teams turn evidence into impact through integrated execution across clinical development, regulatory strategy, and market access. We deliver the projects that make innovation work—faster, smarter, and with excellence built in.           

What Sets Us Apart: We think across the entire product journey — from early evidence generation to payer and policy decisions. Our teams bring scientific, regulatory, and commercial perspectives together from the start, ensuring that every study, model, and communication delivers value across stakeholders. This cross-functional approach reduces rework, shortens timelines, and strengthens the credibility of every outcome. 

The Result: Faster patient access — built on stronger evidence, seamless strategy, and reliable execution. 

Meet Our Team →

The Reality · The Execution Gap

Brilliant Science, Blocked by Execution — What’s Standing in the Way?

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
The Execution Challenges We Solve
Unclear Value Strategy
Misaligned Early Decisions
Reactive Modeling
Costly Late-Stage Pivots
Fragmented Evidence
Inefficient Evidence Generation
Sequential Submissions
Regulatory Risk & Rework
Delayed Access
Missed Launch Momentum
Missed Opportunities
Value Leakage Post-Launch
The Execution Challenges We Solve
Discovery & Early Dev
Target ID → IND
Unclear Value Strategy
Misaligned Early Decisions
Phase I/II Clinical
FIH → PoC
Reactive Modeling
Costly Late-Stage Pivots
Phase III Clinical
Pivotal Trials
Fragmented Evidence
Inefficient Evidence Generation
Regulatory Submission
BLA/NDA → Approval
Sequential Submissions
Regulatory Risk & Rework
Launch Preparation
P&T → Commercial
Delayed Access
Missed Launch Momentum
Post-Launch Lifecycle
RWE → Expansion
Missed Opportunities
Value Leakage Post-Launch
The Arete Approach
From Insight to Access — Integrated by Design
We orchestrate five expert lines of work in one continuous motion — so insights don’t break, they compound.
Explore Our Integrated Pathways
Wave Wave Wave
Clinical Strategy & Evidence
Regulatory Strategy
Scientific Engagement
Market Access
Insight Acceleration
Featured Case studies
Integrated Value in Action
Scientific Engagement Market Access Launch Preparation Post-Launch Lifecycle Oncology & Hematology Rare & Orphan Diseases

Global Value Dossier for Rare Hematologic Therapy

Issue

Precision medicine company faced payer resistance despite breakthrough clinical data for rare hematologic therapy.

Method

Delivered integrated value communication strategy combining therapeutic expertise with market access intelligence.

Achievement

Global value dossier acceptance with scalable communication framework across key markets.


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Clinical Strategy & Evidence Regulatory Strategy Scientific Engagement Phase III Clinical Phase I/II Clinical Regulatory Submission Infectious Disease

Medical Writing Strategy and Regulatory Documents for Global Vaccine Portfolio

Issue

Global vaccine company needed comprehensive medical writing and regulatory documentation across multiple vaccine products for Phase 2 through Phase 3 transition.

Method

Delivered integrated medical writing strategy spanning protocols, investigator brochures, study reports, and regulatory submissions across US, EU, and global markets.

Achievement

Timely Phase 3 study initiation with successful regulatory document approvals across global jurisdictions including submissions to EU-CTR and CBER.


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Scientific Engagement Market Access Launch Preparation Post-Launch Lifecycle Neurology & Neurosurgery Medical Devices & Interventions

Publication Portfolio and KOL Management for Spine Surgery Devices

Issue

A leading medtech company in spine and neurosurgery lacked a clear publication process, limited writing capacity, and needed to better connect clinical evidence with market access value.

Method

We embedded specialists, built publication workflows, and aligned education programs with payer priorities—integrating communications, event insights, and faculty engagement into one streamlined approach.

Achievement

A global communication framework was established, producing 18 publications and accelerating the reach of credible, consistent content that elevated both education and market access discussions worldwide.


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