R.P. Chiacchierini Consulting, LLC
To find out more about our company, personnel, and services, please see the pages below.
Richard P. Chiacchierini
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