Early Phase Development Solutions
We use our clinical pharmacology and pharmacokinetic knowledge to make critical decisions about the viability of your compound, or to assess the potential of an in-licensing opportunity. We apply our expertise to early phase development to maximise the value of the data from your first in man human studies, as well as assessing the impact of clinical trial results on the future design of the clinical development programme.
- Clinical Pharmacology
- Protocol assistance, review & writing
- Clinical study design & evaluation
- Development strategy
- Pharmacokinetic (PK) & pharmacodynamic (PD) analysis and interpretation
- PK/PD Training – external & in house
- Technical due diligence (pre-clinical PK and ADME, clinical pharmacology aspects assessments)
Our expert knowledge, of clinical pharmacology and the regulatory environment, enables us to offer clients an objective input into their regulatory submissions, helping them on their way to achieving global regulatory success.