Biostatistics

Extending Core PK/PD Expertise to Biostatistics

Pharsight  Consulting Services offers broad biostatistical expertise to support optimal trial design decisions, build the right dataset to achieve your target product profile, and perform critical analyses for your submission.

Protocol Study Designs, Statistical Analysis Plans

• Calculation of sample size and analysis of complex designs, in close collaboration with Pharsight 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

CDISC, Dataset Construction and Regulatory Support

• Dataset construction (CDISC, study pooling, SAS transport files, eANDA, eCTD), including Define.xml files
• Customized presentation of Tables, Figures and Listings
• Complementary edit checks prior to 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 Pharsight Consulting Services as your single partner