R.P. Chiacchierini Consulting, LLC

Dr. Chiacchierini provides statistical support for medical device products. He is a former FDA professional with decades of experience in a wide range of therapeutic and diagnostic areas. He provides full statistical services from a study design to final report; provides statistical support and representation throughout the submission process; and reviews work done by other statisticians.

Statistical services include:

• Assistance in protocol development, including refinement of research questions, study design, sample size justification, and description of statistical analysis methods
• Assistance with statistical analysis, programming and reports
• Assistance with comprehensive final data analysis and reports suitable for inclusion in regulatory applications, submissions, presentation and publication
• Preparation of responses to FDA inquiries regarding statistical issues or deficiencies
• Preparation and coordination of meetings with regulatory authorities
• Assistance with product development strategies to optimize likelihood of regulatory approval
• Assistance with Pre-clinical and clinical study design and analysis
• Assistance with design, analysis and interpretation of experimental pre-clinical studies
• Product applications and guidelines
• FDA relationship guidance and dispute resolution
• Performance of interim analysis for regulatory authorities and Data Safety Monitoring Boards