Expertise in Early Phase oncology & rare diseases that delivers results

With our first-hand knowledge and early phase expertise applied, we focus on safety while placing careful attention on each dose and patient need. Partner with us for Early Phase oncology & rare Disease success.

Early Phase oncology & rare disease expertise to drive success

Understanding that flexibility and speed are critical throughout early clinical development, our dedicated experts in early-phase oncology and rare diseases can build both detail and flexibility into program and project planning to maximise success, all while proactively addressing potential challenges related to dosing protocols and adverse events.

An expert early phase team: all with 100% oncology experience

Clinical Operations
Biostatisticians
On-Staff Physicians
Quality Assurance
Clinical Data Management
Drug Safety
Project Management
Technology

Delivering Expertise and Solutions to Achieve Your Phase I & II Trial Goals

FIH and early phase protocol design, compliance, and delivery
Adaptive, Basket, Umbrella, All Comers, Traditional (e.g. 3+3), Innovative (e.g. accelerated titration), Bayesian, etc.
Investigational product changes/issues
Data and statistical considerations, challenges, and review
Enrolment and retention guidance, along with strategies for site engagement
Rare patient populations
Established site relationships
Safety monitoring
Regulatory submission and approvals

First in Human Clinical Trials

First-in-human (FIH) oncology trials shouldn’t be entrusted to just any CRO. It’s imperative to partner with a CRO who has first-hand knowledge and expertise in this critical first step, where a focus on safety is paramount and each dose and patient is given careful consideration and attention.

At Aixial Group, we understand early-phase oncology and rare disease clinical trials demand both expertise and agility. Our dedicated team delivers flexible, precise trial designs focused on patient safety and efficient progress. From first-in-human studies to adaptive and innovative protocols, our team proactively manage risks, ensuring your Phase I & II trial goals are achieved.

Why work with us?