Biostatistics

Accovion’s biostatisticians have extensive knowledge of statistical methodology for drug and device development, various study designs, and regulatory requirements. They are experienced in a broad range of therapeutic areas and add value to your projects. Clients appreciate the reliability and the proactivity of the team.

Experience & Expertise:

  • Planning and Analysis of Phase I – IV Studies and Observational Study
  • Study Design
    • Proof of concept or dose-finding
    • Superiority/Non-inferiority/Bioequivalence
    • Flexible designs
  • Statistical input into Study Protocol/Observational Plan
  • Sample Size Estimation
  • Randomization
  • Statistical Analysis Plan, Table Plan, Table Shells and Analysis Dataset Specifications
  • Statistical Data Review
  • IDMC Support or IDMC Statistician
  • Analysis
    • Interim and final analysis for clinical studies
    • PK and PK/PD Analysis
    • Integrated summary tabulations
    • Data mining and exploratory analyses
    • Meta  analyses
  • Patient reported outcomes and quality of life data
  • Regulatory Support
    • FDA 
    • EMA
    • BfArM 
    • PEI
    • etc.
  • Representation of clients in meetings with regulatory authorities  
  • Reporting services
    • Key results memo
    • Statistical input into clinical study report
    • Manuscript and publication support
    • Statistical input into CTDs including ISS&ISE

Michaela Praus

Michaela Praus
Senior Director Biostatistics

+49 6421 94849-27