Biostatistics

Veristat biostatisticians and SAS programmers apply scientific principles as well as indication-specific knowledge to study design, protocol sample size and endpoint development, creation of analysis plans, SAS programming, and statistical analyses.

Biostatistics and Programming services include:

Study design / protocol development
Statistical consulting
Sample size calculations
Randomization schemes
Statistical analysis plans
Protocol and CRF review
Statistical programming using SAS®
Data conversion
Statistical tables, data listings, and figures for clinical study reports (CSRs)
Statistical analyses and reports
Pharmacokinetic and pharmacodynamic analyses
Statistical representation at FDA meetings
Integrated safety and efficacy analyses (ISS/ISE/CTD)
Data Monitoring Committee services
CDISC-compliant datasets

Data Review Committees

Veristat provides guidance for the establishment and management of Data Monitoring Committees (DMCs) and Clinical Endpoint Committees (CECs). Veristat works with Sponsors to identify thought leaders in the relevant indications, draft DMC/CEC Charters, coordinate DMC/CEC meetings and logistics, and facilitate communication with the members.

DMC/CEC services include:

Identification and recruitment of experienced members
Charter development
Independent data analysis
Meeting coordination
Safety report generation
Meeting minutes
Management of safety recommendations