I have experience with non-clinical, pre-clinical, and clinical trials in the biotech and pharmaceutial communities across a wide range of indications including endometriosis, insomnia, psychosis, cancer, malaria, HIV, rheumatoid arthritis, psoriasis, and multiple sclerosis.  I are best at hands-on operational level statistical support of clinical trials involving protocol review, statistical analysis plan development and review, review of tables, figures, and listings, and writing and review of clinical study reports.  Please select from the tabs on the left for more information regarding our areas of specialty.

Phase I Studies

• First in man
• Dose finding and escalation studies/maximum tolerated dose
• Absorption, distribution, metabolism, and excretion studies
• Pharmacokinetic/Pharmacodynamic studies
• Cardiac safety/QT interval studies
• Food effect studies

Phase II/III Studies

• Safety and efficacy
• Proof of concept
• Adaptive designs
• Interim analyses

Non-Clinical and Pre-Clinical Studies

• Stability data analysis for investigational product;
• Allometric scaling.