Extending Core Pharmakinetics/Pharmacodynamics (PK/PD) Expertise to Biostatistics

Certara Strategic Consulting offers biostatistical expertise to support optimal trial design decisions, build the right dataset to support critical analysis for your submission, and perform these analyses.

Protocol Study Designs, Statistical Analysis Plans

  • Calculate sample size and analysis of complex designs, in collaboration with our PK/PD scientists

Data Summarization for Phase I-III
Programming of Tables, Figures and Listings

  • Efficacy parameters (primary and secondary endpoints)
  • Safety (adverse events)
  • Tolerability (laboratory parameters)
  • Baseline characteristics

Inferential Statistics (Biostatistics) in Phase I-III Studies

  • ANOVA, ANCOVA
  • Nonparametric test, survival analyses

Dataset Construction and Regulatory Support

  • Dataset construction (Clinical Data Interchange Standards Consortium (CDISC), study pooling, SAS transport files, eANDA, eCTD), including Define.xml files
  • Customized Tables, Figures and Listings (TLFs)
  • Complementary edit checks prior to database lock
  • Support for advisory committee and DMC meetings

Benefits

  • Tight integration of safety/efficacy results with PK data and underlying dose-exposure-response - critical for submission
  • Efficiency and convenience of Certara Strategic Consulting as your single partner


Certara Strategic Consulting uses biostatistics to provide model-based decision support at any stage of drug development or across entire programs.