FDA Statistics
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FDA Statistics Employees
FDA Statistics Details
FDA Statistics is a consulting group whose purpose is supporting your FDA and other regulatory submissions. We have extensive experience in drug and device trials and are well versed in the relevant regulations, both in the United States and internationally.Services:Study & Protocol DevelopmentStatistical Analysis Plan WritingPatent WritingGrant WritingJournal Article WritingAnalysis of Clinical TrialsProject Management and ImplementationDetailed Participant Accural PlansMeeting FacilitationProject Evaluation (Process and Outcome)Report WritingOn-site AuditingGenomicsAnalysis of Diagnositic TestsSurvival AnalysisStatistical Analysis of SignalsQuality:All of our work takes place within the framework of a Quality System. All of our statistical analyses can be performed within the guidelines of 21 CFR 11. Our goal is to provide you with the highest quality analysis to ensure that your submission process is as smooth as possible.
