About Axella

Built by people who have run trials from the inside.

Axella Research was founded to connect medical innovators with the infrastructure, patients and practical expertise of a community-based physician network, and to close the gap between promising science and the clinic.

Our story

Bridging the gap.

Too many promising therapies, devices and diagnostics stall between the lab and the patient. The obstacles are rarely the science. More often it's the cost, the regulatory complexity and the difficulty of finding sites that can actually enroll.

Axella grew out of community medical practice, with its deepest roots in oncology and urology. We pair the everyday clinical judgment of practicing physicians with senior regulatory and operations leadership, and we run our studies on integrated digital workflows that keep costs down and sponsors informed.

The result is a CRO sized for emerging sponsors, with the experience to take a program from its first FDA conversation through its last patient visit.

Phase I–IVClinical trial experience across drugs, biologics, devices and diagnostics

45+ yearsHands-on clinical operations experience in our leadership

30+ yearsFDA regulatory and clinical development experience

One teamFrom regulatory strategy through study close-out

Leadership

The people on your study.

Three complementary leaders cover the whole path: how a study is funded, contracted and staffed, how it gets through the FDA, and how it runs at the site. The leaders you meet during scoping are the leaders who run your program.

Avi Kamelhar, MPA

Founder & Chief Executive Officer

Avi brings the operator's view of clinical research: how to build the site network, structure the deal and control the budget so a promising program actually reaches patients.

25+ years building and running physician networks and practices
Contract and budget negotiation with sponsors and sites
Financial modeling for studies and flexible partnership structures
Process improvement that takes cost out of trial delivery

Background

Avi began his career directing outpatient network development at Staten Island University Hospital. After earning a Master's degree in Health Finance from NYU, he built and led a multispecialty physician group serving the greater New York area. He founded Axella Research to put that clinical infrastructure and research experience to work for medical innovators.

Regulatory Affairs

Vice President · Ph.D., RAC

Our regulatory lead brings the regulatory judgment that decides how fast a program moves: which studies the FDA will expect, how to frame the IND, and how to get the most out of every agency interaction.

30+ years in regulatory and clinical affairs
Pre-IND strategy, IND filings and FDA liaison
Drugs, biologics, devices and diagnostics, in the US and internationally
Protocol design and clinical and regulatory writing

Background

Senior regulatory and clinical affairs roles at pharmaceutical and medical device companies, including global pharma, with product work spanning oncology, diagnostic imaging and cardiology, and advisory work on rare metabolic disease programs.

More than 40 publications, university teaching experience, a Ph.D. in Pharmacology, and Regulatory Affairs Certification (RAC).

Research Operations

Vice President

Our operations lead brings more than 45 years of experience from every seat at the trial: coordinator, monitor and project manager. Your study runs to protocol, your sites stay supported, and your data holds up to an audit.

45+ years of hands-on clinical and research experience
Site start-up, training, monitoring and close-out
IRB and IND submissions, SOPs and inspection readiness
Nursing background focused on patient safety and retention

Background

Has managed projects and clinical operations for Axella since 2017, overseeing study start-up, site training, vendor selection, specimen logistics and day-to-day trial delivery.

Built the clinical research program at a large imaging practice as an investigational site and central reader, and runs an independent monitoring practice that has initiated, monitored and closed out multicenter studies. A licensed practical nurse, trained in GCP, ICH guidelines and IATA dangerous-goods shipping.

What we believe

Principles we work by.

Patients first

Care comes first

Our investigators treat patients every day. Protocols that respect patients' time and care get better data and better retention.

Candor

Straight answers

Realistic timelines, transparent budgets, and early warning when something changes. No surprises at the next invoice.

Quality

Inspection-ready

GCP and ICH E6 in every process, with every action documented and traceable.

Let's talk about your program.

A 30-minute conversation is usually enough to know whether we can help.

Start a conversation →