The Statistical Services group provides statistical support for device and biologic products. Our statisticians, former FDA and industry professionals have decades of experience in a wide range of therapeutic areas. We can provide full service from a study design to final report and representation or provide services on a consultancy basis. However, when our services are utilized, our senior-level staff is directly involved and the client benefits from their expertise.

Statistical services include:

• Assistance in protocol development, including refinement of research questions, study design, sample size justification, and description of statistical analysis methods
• Statistical analysis, programming and reports
• Comprehensive final data analysis and reports suitable for inclusion in regulatory applications, submissions, presentation and publication
• Support for preparation of regulatory submissions
• 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
• Pre-clinical and clinical study design and analysis
• 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
• Computerized patient randomization
• Design of experiments for manufacturing in-process, end-stage quality control, and product development and evaluation