Data Analysis

Katalyst’s Statisticians & Statistical Programmers provide expert knowledge of wide Therapeutic Areas & Regulatory Standards including:
  • cGCDMP
  • 21 CFR Part 11
  • SDTM
  • ADaM
  • Global Regulatory Guidelines

Our team of biostatistician and statistical programmers provide a full range of biostatistical services including sample size calculations, randomization schedule generation, blinding and unblinding procedures, statistical analysis plans and statistical analyses.

Biostatistics Services:

  • Clinical Trial Study Design
  • Study Sample Size Calculations and Randomization.
  • Statistical Inputs to Clinical Study Protocol Development
  • Statistical Analysis Plan (SAP) Development and Interpretation
  • Statistical Reports

Statistical Programming

  • SAS Programming as per CDISC (SDTM/ADaM) Standards
  • Performance of Statistical Analysis
  • Generation of Tables/Listings/Graphs (TLGs) and Validation
  • Generation of Tables/Listings/Figures (TLFs) and Validation
  • Performance of interim Statistical Analysis
  • Stand-alone Statistical Reports
  • Clinical Statistical and Study Reports Writing
  • SAS Datasets Creation as per CDISC
  • Program Validation
  • Integration of Databases Across Protocols
  • Integrated Summaries of Safety and Efficacy (ISS & ISE) for Regulatory Submissions.
  • Summary of Clinical Safety and Efficacy (SCS & SCE) for Regulatory Submissions.
  • Data derivation and mapping to CDISC standards
  • Implementation of CDISC SDTM and ADaM standards