EmpiriStat - Clinical Trials and Epidemiological Research Experience

EmpiriStat's Methodologies Adapt to Every Industry and Therapeutic

EmpiriStat has collaborated with clients and organizations in almost every industry and specialty—both in the U.S. and countries around the world. We've developed and refined a rigorous, effective foundation of methodologies that are fluid yet repeatable—enabling us to quickly adapt to each new project and provide the high level of personal service and reliability that are the core of our reputation.

Government

EmpiriStat works closely with government entities such as the United States Department of Defense (DoD) and the National Institutes of Health, and performs 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

Non-Profit Organizations

EmpiriStat works 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

Private Industry

EmpiriStat provides a wide range of services to private companies like Alexza Pharmaceuticals, Soluble Systems, and Research & Diagnostic Antibodies, including

Consulting for integration of statistical analyses in FDA New Drug Applications (NDAs)
Grantwriting and funding support
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)
Providing management strategy and design methodology for clinical and health research
Design, management, and clinical monitoring of clinical studies

Academia & Private Practice

EmpiriStat collaborates 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