Expertise, Scale, and Trust in First-in-Human and Early Development
At Aixial, we believe early phase trials—especially first-in-human (FIH) studies—set the tone for the full lifecycle of drug development. With deep therapeutic expertise, cross-regional capabilities, and proven operational performance, Aixial is the CRO partner of choice for biotech and pharma sponsors launching complex early phase programs.
Aixial has a track record you can trust
We’ve delivered:
- 100 First in Human (FIH) studies
- ~580 Phase I and Phase II clinical trials
- 250+ oncology trials, including cell/gene, and radioligand therapies
- 19 therapeutic areas, including rare and orphan indications
- Support for adult and pediatric populations
- Trials up to 4,000 patients and 88 sites
- Coverage across APAC, Europe, North and South America
The global early phase clinical trial outsourcing market, encompassing Phase I and I/II studies, was valued at approximately $17.97 billion in 2024 and is projected to reach $30.74 billion by 2032, growing at a CAGR of 6.94% during the forecast period. globalgrowthinsights.com
Aixial delivers confidence where it counts
This growth is driven by increasing demand for innovative drug development, rising R&D investments, and the need for specialised expertise in early-stage clinical trials. Outsourcing these trials allows pharmaceutical and biotechnology companies to streamline processes, reduce costs, and enhance efficiency in drug development and regulatory approvals.globalgrowthinsights.com+1gminsights.com+1
Given this expanding market, Aixial’s extensive experience in early-phase research positions it as a valuable partner for sponsors seeking to navigate the complexities of early-stage clinical development.
“No matter the modality—drug, device, diagnostic, nutraceutical, or combination product—Aixial has delivered early phase trials with precision, regulatory clarity, and speed.”
These trials span a range of innovative designs, including 3+3, Bayesian, basket, umbrella, and accelerated titration models.
Specialised Early Phase Teams
Dedicated project managers, on-staff physicians, biostatisticians, data managers, and drug safety professionals with deep FIH expertise.
Therapeutic and Modal Flexibility
We work across modalities—cell, gene, immunotherapy, radiopharmaceuticals, small molecules, and more.
Strategic Global Reach
With operations spanning APAC, Europe, North America, and Latin America, we support global trial setup, site engagement, and regulatory alignment.
Technology-Enabled Execution
From decentralised elements to real-time data dashboards, our tech stack accelerates enrollment and improves decision-making.
Rare and Orphan Indication Focus
We bring niche recruitment strategies, established site relationships, and experience managing rare and pediatric cohorts.
How can we support your next project?
Whether you’re looking for a protocol review or a proposal,
simply reach out to us by filling our request for proposal.