Fda Statistics

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 Development Statistical Analysis Plan Writing Patent Writing Grant Writing Journal Article Writing Analysis of Clinical Trials Project Management and Implementation Detailed Participant Accural Plans Meeting Facilitation Project Evaluation (Process and Outcome) Report Writing On-site Auditing Genomics Analysis of Diagnositic Tests Survival Analysis Statistical Analysis of Signals Quality: 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.