With our first-hand knowledge and expertise applied, we focus on safety while placing careful attention on each dose and patient need.
WHEN THERE IS A LOT AT STAKE, WE PUT YOU ON THE PATH TO 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 Data Management
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
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, encapsia.
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
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.
How can we support your next project?
Check out our insightful resources
OTHER WAYS WE SUPPORT YOU