Statistical Programming And Biostatistical Services

Our experienced Statisticians and Clinical SAS Programmers help our customers in the analysis and reporting of different phases of Clinical trial.

We Provide

Statistical Programming Services:

  • Analysis Datasets - Create Analysis Datasets.

  • TLF’s - Generation of Tables, Listings and Figures as per Statistical Analysis Plan

Biostatistical services:

  • Interim Analysis offered with unblinded statistical support and advice

  • PK/PD analysis by modelling the relationship between exposure and response using non-linear models and non-linear mixed effect modelling

  • ISS/ISE – Support for the integration of safety and efficacy data provided prior to the regulatory approval

  • Pre-clinical studies support that ensures fulfilment of study objective

  • Protocol inputs including clinical study design, sample size calculations and consultancy advice

  • Statistical Analysis Plan and TLF shells provided

Our experienced Statisticians and Clinical SAS Programmers help our customers in analysis of clinical trials of all types including parallel, crossover, multi-phase and PK/PD studies. Our statisticians and SAS Programmers are committed to follow SOPs and ICH guidelines. We are flexible in producing reports in sponsor-defined format or our standard formats. Our processes and procedures are well documented to help produce high quality outputs on time. Our statistical programming services include

  • Sample Size Calculation

  • Statistical Analysis Plan

  • CDISC SDTM Mapping and Conversion

  • Generation of ADaM (Analysis Data Model)

  • Analysis and reporting(TLF programming) of clinical trial data

  • Interim Analysis

  • PK/PD Analysis

  • ISS/ISE (Pooled) Analysis