EmpiriStat provides a wide range of services to a broad depth of pharmaceutical, biotech and device companies like Alexza Pharmaceuticals, Soluble Systems, Research & Diagnostic Antibodies, Eli Lilly, Xeris Pharmaceuticals, CyMedica, NKMax America, including

• Consulting for integration of statistical analyses for Regulatory Submissions (NDAs, BLAs, MAAs)
• 510(k) and PMA support
• In-vitro device trial support
• Validation of final statistical results for an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
• CDSIC Programming for Submissions
• Providing management strategy and design methodology for clinical trials Phase 1-4; RWE studies
• Data and Safety Monitoring Boards and Reports

EmpiriStat has collaborated with academic institutions like the Schulze Diabetes Institute at the University of Minnesota and Coastal Carolinas Integrated Medicine on tasks including

• Regulatory strategy for studies leading to a Biologics License Application (BLA) with the FDA
• Clinical data management, project management, biostatistics and clinical monitoring
• Clinical trial support and statistical analysis for IND studies
• Grant writing support and strategy

EmpiriStat has worked with non-profit organizations like the United Network for Organ Sharing (UNOS), The Henry M. Jackson Foundation for the Advancement of Military Medicine and the United States President's Emergency Plan for AIDS Relief (PEPFAR) performing such tasks as...

• Design of domestic and international epidemiologic studies
• Health Survey and Questionnaire Design and implementation strategies
• Process and management approach for effective data collection and statistical practices
• Final statistical analyses for study reports and manuscripts
• Scientific mentoring of scientists and validation procedures
• Clinical Trial Training of clinicians, nurses and research staff in East and West Africa

EmpiriStat has worked closely with government entities such as the United States Department of Defense (DoD) and the National Institutes of Health, and has performed tasks including...

• Clinical Data Management
• Biostatistics and Statistical Programming
• Safety Monitoring and Reporting
• Project Management
• Regulatory Processes and Management of Investigational New Drug Applications (INDs)
• Safety Monitoring and GCP Training