Statistical Consulting

Our consultative services include:

  • Study Planning - Protocol Development
  • Clinical Advisory Groups: drug development, scientific, statistical & trial design consulting
  • Literature review, re-analysis / meta-analysis of reference studies
  • Review and analysis of preclinical studies (toxicity, PK)
  • Analysis in supports of the safety and efficacy sections of IBs
  • Simulation studies
  • Study design, sample size/power calculation, statistical considerations, randomization, including adaptive methods
  • Client representation or support at IND / pre-study regulatory meetings.