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.