Our experience in First-In-Human and Early Phase Oncology Trials

Overview of Aixial Group’s in-depth experience in the areas of First-In- Human and early phase oncology trials, and why it’s so important to have the most experienced partner by your side when there’s a lot at stake.

First-in-human (FIH) oncology trials shouldn’t be entrusted to just any CRO. It’s imperative to partner with one 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 attention.

Understanding that flexibility and speed are also vital to this first stage of clinical development, our resident early phase oncology and rare disease experts can build both detail and flexibility into program and project planning issues with dosing protocols and adverse events.

100+ FIH Studies
Specialist early phase medical and operations staff
44,500 Oncology patients
Focused on oncology and rare disease
250+ Oncology studies
100% Oncology experienced project teams

Aixial puts your FIH and early phase trials on a path to success

An expert early phase team

Clinical Operations
Clinical Data Management
Biostatisticians
Drug Safety
On-Staff Physicians
Project Management
Reliability, flexibility, and confidence
Technology

Significant experience and solutions to ensure your oncology trial goals are met

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
Safety monitoring
Enrolment and retention guidance, along with strategies for site engagement
- Rare patient populations
- Established site relationships
Regulatory submission and approvals

Project timelines can be reduced by weeks or months by our experts through protocol adjustments, intelligent use of decentralized services, and real time data visibility via
our powerful, holistic technology platform.

Instant access to all trial data, no matter the source
Insights that are actionable instantly via live data
Full compatibility with any mix of EDC, eSource,
and third party data sources

FIH and early phase oncology trials benefit from an Aixial partnership
Aixial prides themselves on being a seamless extension to sponsor teams and offers stable, loyal expertise with the right technology, making every clinical trial safer and more efficient, no matter the complexity.