Regulatory strategy
Pre-IND meetings, IND preparation and submission, FDA correspondence and a clear route to approval.
Bridging science and patients
From first FDA meeting to last patient visit.
Axella Research is a full-service clinical research organization for emerging biopharma, device and diagnostic companies. We combine regulatory strategy, a community-based physician network and technology-integrated operations to move your program forward faster, and at lower cost.
Fee-for-service or shared-risk partnership. See how we invest →
Phase I–IVDrugs, biologics, devices and diagnostics
45+ yrsHands-on clinical operations leadership
30+ yrsFDA regulatory and clinical development
US-wideCommunity-based study sites across the country
Why Axella
Big-CRO capability. Small-team accountability.
Emerging sponsors deserve more than a junior team and a change-order habit. We stay small by design, so the senior people who scope your study are the ones who run it.
01
Regulatory depth
Decades of FDA experience across pre-IND strategy, IND submissions and clinical development, for US and international sponsors.
02
Sites that enroll
A network of community-based study sites across the United States, with particular depth in oncology and urology, that puts your protocol in front of the right patients sooner.
03
Leaner operations
Integrated digital workflows replace spreadsheets and hand-offs, so budgets, documents, visits and payments stay in one place and costs stay down.
What we do
Full-service support, or exactly the piece you need.
Engage us end to end, or bring us in for a single function. Either way, you get one accountable team.
Clinical operations
Feasibility, site start-up, monitoring and close-out, managed to protocol, GCP and ICH E6.
Site network & SMO
Community practices with coordinators and study nurses experienced in running trials alongside patient care.
Protocol & medical writing
Protocol design, informed consent, investigator brochures, safety narratives and study documentation.
Biostatistics & data management
Study design and sample size, eCRFs, data cleaning, statistical analysis and CDISC-standard datasets for submission.
Project management
A single point of accountability for timelines, vendors, budgets and contracts, with real-time status reporting.
Shared-risk partnership
Your science. Our services. Shared risk.
For promising early-stage programs, we don't just bill hours. We can take part of our fee in equity, royalties or milestones and, case by case, co-fund clinical development alongside you. When your program succeeds, so do we.
01
We review your programScience, regulatory path, IP and market, under NDA.
02
We structure the partnershipA mix of cash fees with equity, royalties or milestones, and co-funding where it fits.
03
We run it togetherThe same senior team takes your program from the FDA to the clinic.
Therapeutic expertise
Broad reach, proven depth.
We support programs across therapeutic areas and product types. Oncology and urology are where our track record runs deepest, but our regulatory, operations and data teams don't stop there.
Deep experience
Oncology & hematology
Medical oncology, hematology, radiation oncology and breast surgery, from investigator-initiated studies to sponsor-led programs.
Deep experience
Urology & uro-oncology
Drugs, devices and in-vitro diagnostics, including bladder and prostate indications and functional urology.
Across medicine
And beyond
- Immunotherapy
- Vaccines & infectious disease
- Women's health
- Rare & metabolic disease
- Devices & diagnostics
Plus affiliated physicians across many other specialties.
Our approach
One team across the whole path.
Every hand-off between vendors is a place where time and budget leak. We carry your program through each stage with the same people and the same system.
Strategy
Development plan, gap and risk analysis, study design and sample size.
Regulatory
Pre-IND meeting, IND submission, IRB approval.
Start-up
Feasibility, site selection, contracts, budgets, SIVs.
Enrollment
Community sites recruit and consent the right patients.
Conduct
Monitoring, data review, safety reporting, site payments.
Analysis & close-out
Database lock, statistical analysis, TMF completion and reporting.
Technology-integrated operations
Less administration. More research.
Our workflows run on a modern, unified clinical operations platform, so your study doesn't depend on email threads and spreadsheets.
- Real-time visibility. Enrollment, visits, documents and budget status on demand, not in next month's report.
- Faster start-up. Budgets, regulatory documents and site onboarding run in one governed workspace.
- Sites paid on time. Visit-driven payment tracking keeps investigators engaged and enrolling.
- Audit-ready by default. Every action is traceable, with controls designed around 21 CFR Part 11 principles.
Axella's operations are built on Ecosera, an open clinical research platform available to sponsors, CROs and sites.
Ways to work together
Flexible models for emerging sponsors.
Full service
End-to-end program
Regulatory, operations, sites and data under one team and one contract, from strategy through close-out.
Functional
Targeted expertise
Engage us for a single need, such as an IND, monitoring or project management, and we integrate with your existing vendors.
Aligned partnership
Shared-risk development
For promising early-stage technologies, we may take part of our fee in equity, royalties or milestones, and case by case co-fund development costs. Evaluated case by case.
We've done this before: a Phase II nocturia program for equity, and a bladder cancer diagnostic for royalties.
Selected engagements
From concept to clinic.
Mid-stage programs in oncology, urology and vaccines, run from regulatory planning through trial conduct.
Immunotherapy for metastatic colorectal cancer
CRO for a clinical-stage immunotherapy company's Phase II open-label study of an investigational cell-based immunotherapy as third-line treatment for metastatic colorectal cancer, covering study management, regulatory submissions and site operations.
Investigational oral therapy for prostate cancer
CRO for a publicly traded oncology company's multicenter, open-label dose-escalation study of an investigational oral combination therapy in patients with prostate cancer, covering site selection and contracting across community urology and oncology practices, site budgets and payments, drug supply and study management.
Novel drug combination for nocturia
Took the program from protocol development, manufacturing guidance and pre-IND meeting through IND activation and a Phase II trial, in exchange for equity.
Anti-viral immunomodulatory vaccine in older adults
CRO for a clinical-stage immunotherapy company's study of the safety and efficacy of an investigational anti-viral immunomodulatory vaccine in healthy elderly adults, from site activation through trial conduct.
Have a program ready for the clinic?
Tell us where you are. We'll respond within one business day with a clear view of the path forward, whether or not we're the right fit.