Premier Research’s biostatisticians, biostatistical programmers, and pharmacokineticists understand that well designed studies with appropriately planned and communicated data analyses are the key to obtaining clinical trials results that support development of your compound or device.

Our biostatisticians work with our clients to determine the optimal cost effective methods for collecting, analyzing, and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs. Solid statistical data analysis depends on careful planning, and a statistician is involved throughout the lifespan of a project. 

Maximizing Efficiencies
Premier Research utilizes the Parallel Processing Approach™ (PPA). PPA has been established in-house for a number of years and successfully implements cost-effective high quality, rapid execution of biometrics study tasks.

Services

• Regulatory Statistical Consulting and  Representation
• Integrated Clinical/Statistical Development Programming
• PK/PD Model Development and Analysis
• Design a nd Analysis of Clinical Trials
  • Study Design and Analysis Planning
  • Statistical Analysis Plans
  • Sample Size Calculations a nd Simulations
  • Statistical Methods for Protocols
  • Protocol and CRF Consultation and Review
  • Randomization Schedules
  • Interim Analysis and DMC Support
  • Statistical Programming and Modelin
  • Table, Listing, and Figure Generation
  • Statistical Reports (CSR, Manuscripts, IB) 
• Design and Analysis of Observational, Registry, and Rx-to-OTC Switch Studies
• Health Outcome, Pharmacoeconomic, and Quality of Life Analyses
• Large-Scale Data Warehousing and Integration
• ISS/ISE Planning, Analyses, and e-Submissions
• Data Monitoring Committee Support and Participation
• CDISC Compliant Dataset Development 
• Manuscript Preparation and and Meeting Presentations
• Marketing Support