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Early Clinical Development

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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