Bittman Biostat, Inc.

Statistical Consulting for Pharmaceutical & Device Development   

Services for product development

Develop and execute clinical trials
	Protocol design: sample size, power, interim analysis, statistical methods
	Modeling of clinical trial outcome scenarios
	Randomization schedules
	Statistical Analysis Plan: prepare methods, mock tables and graphs
	Programming for analysis tables, listings, figures and statistical reports
Lead Data Safety Monitoring Boards (DSMBs) and data coordinating groups
	Serve as DSMB Chair
	Head the unblinded data coordinating group
	Write charters
Join sponsor in regulatory interaction
	Pre-IND, End of Phase 2, pre-submission meetings
	NDA/BLA/PMA preparation
	Responses to queries and critiques
	Advisory Committee preparation
Work with CEOs and CFOs
	Due diligence evaluation of in-licensing or defense of out-licensing candidates
	Clinical trial outcome scenarios for investment decisions
	Relationship management with contract research organizations
	Vendor proposal and budget assessment
Strengthen client’s infrastructure
	Write statistical Standard Operating Procedures (SOPs)
	Statistical software validation
	Peer review and independent verification of results
Design non-clinical experiments (DOE)
	Stability (shelf-life)
	Process and yield optimization
	Comparability studies
	Formulation development
	Assay validation
Optimize client benefit from vendors
	Provide statistical specifications for randomizations, Interactive Voice Response Systems and electronic diaries
	Review vendor deliverables
Provide other targeted solutions
	Serve on mock Advisory Committee and Dispute resolution panels
	Data analysis for manuscripts and presentations
	Exploratory data analysis, post-hoc and meta-analyses
	Statistical method development

FOR INFORMATION PLEASE CONTACT:
Dr. Richard M. Bittman
9047 Cherry Oaks Trail #202
Naples, Florida 34114
Phone: 239.970.0536
Email: rmb@bittmanbiostat.com