We are transforming the clinical trial process utilizing innovative approaches to study design including:
- Fast-Track Development
- Using combined and varied models, Phase I-IIa can be completed within 6 months
- Adaptive Umbrella-Protocol Design
- Single- and multiple-ascending dose studies are conducted simultaneously reducing development timelines by 6-8 months, resulting in considerable cost savings and reducing time to market
- Microdosing (Phase 0 )
These unique studies use a fractional dose, which is tracked through the body using a low-dose 14C radiolabel tag and analyzed using Accelerated Mass Spectrometry (AMS) technology. AMS data allows pharmacokinetic (PK) calculations that aid lead-compound selection. Microdosing studies allow us to answer all your questions for unique PK situations such as:
- Determination of Absolute Bioavailability as part of a first-in-man study
- ADME (absorption, distribution, metabolism and excretion) for compounds in variety of difficult situations (long half-life, limited clinical quantity, narrow therapeutic index, limited toxicology data)
