Early Clinical Development
First in Human to Proof of Concept
Early Clinical Development refers typically to Phase I and Phase IIa studies. The main objectives of these early clinical studies are to investigate the safety and tolerability, pharmacokinetic (PK) / pharmacodynamic (PD) properties of an investigational drug, as well as to explore its efficacy.
We offer integrated clinical research services executed by our experienced and dedicated early development team:
- Strategic consulting of clinical development plan
- Site feasibility
- Site management
- Project management
- Data management
- Biostatistics
- Programming
- Clinical PK/PD and pharmacometrics
- Medical monitoring
- Medical writing