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 also vital to these stages of clinical development, our resident early phase oncology and rare disease experts can build both detail and flexibility into program and project planning to maximize success, all while mitigating potential issues with dosing protocols and adverse events.

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

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

Significant experience and solutions to ensure your Phase I & II 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
Enrollment and retention guidance, along with strategies for site engagement
Rare patient populations
Established site relationships
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 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 to maximize success, all while mitigating potential issues with dosing protocols and adverse events.

Why work with us?