The clinical partner built for startups & brands
the big CROs won't call back.
Axon Clinical Research delivers full-service clinical trial services to U.S. startups and emerging brands that need rigorous study design and execution — without the minimums, the delays, or the inaccessibility of large-scale contract research organizations. We specialize in single-site and multi-site safety and efficacy studies for consumer health, beauty, haircare, OTC, and other emerging product categories, managing every phase from protocol development through study closeout.
There is a significant and underserved market of innovative founders with differentiated products who need clinical substantiation to reach retail, satisfy investors, or establish safety records — and no clear path to get there. Axon is that path.
Protocol Development
Study design, endpoints, inclusion/exclusion criteria, and statistical considerations tailored to your product category and regulatory pathway.
IRB Submission & Management
End-to-end IRB strategy, submission, response management, and ongoing compliance — including cosmetic and OTC studies where IRB is best practice.
Site Identification & Oversight
Site qualification, setup, and monitoring. We partner with credentialed physician investigators and manage all site-level operations on your behalf.
Study Documentation
Informed consent forms, CRFs, investigator brochures, regulatory binders, and all required study documentation built to standard and audit-ready from day one.
Safety Monitoring & AE Reporting
Adverse event tracking, medical review, and reporting procedures ensuring participant safety and sponsor protection throughout your study.
Clinical Trial Agreements
Sponsor-site agreements, indemnification structures, and insurance coordination so every party — sponsor, site, and investigator — is properly protected.
Investigator & Site Fee Negotiation
We build and negotiate the full study budget on your behalf — including investigator fees and site fees — so sponsors know exactly what they're paying for.
Regulatory Pathway Guidance
We help you understand your FDA classification and regulatory obligations before you build your study — not after. Cosmetic, OTC, or IND — we know the difference.
Discovery Call
Budget Proposal
Agreement
IRB Build-Out
& Reporting