Applied Statistics & Consulting

Services for The Pharmaceutical Industry
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Applied Statistics and Consulting specializes in experimental design of phase 1-3 clinical trials, with particular experience in Phase I crossover designs.  However we can also provide assistance with pre-clinical (animal) data and Phase 3b-4 clinical trials.  Specifically, we provide the following services to our pharmaceutical industry clients:

  • Assistance with Protocol Development
  • Attend FDA Meetings
  • Assistance with and Attending Advisory Meetings
  • Assistance with Product Development plans
  • Write Analysis Plans
  • Assistance with Clinical Study Reports and Manuscripts
  • Sample Size Calculations
  • Randomization Schedules (generating and holding)
  • Data Safety Monitoring Board (DSMB) Participation
  • Electronic Data Capture (EDC) Experience
  • Review of Data Management Plans (Edit checks)
  • Review of Database Specifications (e.g., mapping, formatting)
  • Analysis of genomics data
  • Design and analysis of microarray data

Applied Statistics and Consulting is niche consulting practice. It is NOT a Contract Research Organization (CRO).  In other words, Applied Statistics and Consulting will not design, manage or integrate databases.  Nor will we produce large volumes of tables, listings and figures for regulatory reporting.  We also do not pretend to be regulatory consultants, or manufacturing experts.  Fortunately, Applied Statistics and Consulting has relationships with several small CROs and individuals who specialize in such areas and we would be happy to introduce you to them or even act as liason with them if you would like the relationship to remain streamlined.

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Applied Statistics and Consulting:  "It's not just about the numbers."

1205 Chestnut Mountain Road

Spruce Pine, North Carolina  28777

Phone: 828-467-9184