Biostatistics and Programming Services in Ahmedabad, India

With the increase in the data analysis and the changing regulatory era, this service is one of the most important aspects which provides an overview of the trial results. The entire output of the trial depends on the statistical analysis data and at Velocious Clinical Research, Bio-statisticians provide the highest level of scientific data with high quality and integrity.

Our Biostatistics and SAS Programming service includes following task (Integrated/ Standalone) :

Statistical Analysis
Statistical programming and creations of mock shells
Input to Study Design (including adaptive designs) and sample size calculation
Statistical Analysis Plan (SAP), mock tables development
Guidance to programmers and review of Tables, Listings, Graphs (TLGs)
Statistical Report and input on the Clinical Study Report (CSR)
Pharmacokinetic and Pharmacodynamic analysis and modeling
Interim analysis and support to Data and Safety Monitoring Boards (DSMBs)
Exploratory analyses for publications, abstracts, and marketing, including meta-analysis
Develop Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets and define.xml
Programming support for Clinical Study Report (CSR), Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) submissions and various other submissions during the conduct of clinical trials
Ad-hoc programming for support of Statistics, Clinical Operations, Data Management and Regulatory functions
Support Interim analysis, Data Monitoring Committee meetings, Database lock related activities and regulatory submissions activities
Data conversion, migration, legacy to standard or SDTM/CDISC mapping and conversion between different standards
Develop customized solutions for process standardization for clients and building standard macros as per client requirements