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327 E. Ridgeville Blvd, #122
Mount Airy, MD 21771-3900

240.744.0000

866.935.STAT (7828)

866.276.STAT (7828)

info@empiristat.com

www.empiristat.com

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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