Clinical Development

Specific clinical development offered

  • Translation of discovery to proof of concept and first in man study
    • Prioritization and indication assessment for Phase II studies
  • Clinical strategy/conceptualization, hypothesis, milestones definition and evaluation
  • Protocol development and adjustment
    • Proposal of sample size, sample size optimization & variability estimations
    • Study population

Specific development services offered 

  • Development strategy and support
    • Treatment difference estimation using in vitro data, in vivo correlation
    • Inhalation drug product development
    • Generic drug product development
  • Pharmacokinetic (PK) expertise and statistics
  • Data mining, root cause analysis of unsuccessful developments
  • Cost effective solutions and risk analysis
    • CRO tendering and risk analysis
    • Evaluation of the development projects for investor in and out licensing
    • Regional product extensions requiring repeat bioequivalence and other studies