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 in oncology and rare disease
  • 250+ Oncology studies
  • 100% Oncology experience 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 trials 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 chnages/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 offer stable, loyal expertise with the right technology, making every clinical trial safer and more efficent, no matter the complexity.

  • 100% of Aixial clinical staff and oncology experts
  • 100+ First-in-Human trials
  • 250+ Oncology studies delivered

Let’s chat and see what our experts can do for your next FIH and early phase oncology trial.

Reach out to us at info@aixial.com

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