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