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BIOSTATISTICAL ANALYSIS OF CLINICAL DATA

BIO-STATISTICAL DATA PLANNING, ANALYSIS & REPORTING OF RESEARCH RESULTS

With the implementation of revised GCPs (ICH E6 Rev 2), scientific integrity of research results requires a holistic approach to data quality now more than ever. The timing, scrutiny, and thoroughness of data recording have to be congruent with the importance of those data to the overall product story. Accudata Solutions uses a comprehensive and integrated approach to data capture, analysis, presentation, and interpretation.

Clinical Data Analysis Biostatistics Research Pharmaceutical Medical Device Diagnostics Nonclinical

We provide:

  • Generation of randomization schemes

  • CRF/eCRF design

  • Edit checks, consistency checks, logic checks, data reconciliation

  • Production of Tables, Listings, and Figures for Clinical Study Report

  • Simulations, bootstrapping

  • Management/oversight/QC of CRO activities

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