Having the right data to differentiate requires a specialized team with years of experience in clinical trials. What's more, if you correctly design your study, you may be able to collect less data and still substantiate your claims and complete your trial earlier than anticipated.

Sristek has built a highly qualified team of specialized statisticians, SAS programmers and medical writers with this level of experience in building efficient trial designs. We approach every study with the endpoint in mind by applying our clear understanding of regulatory requirements, statistical programming applications and experience in a variety of therapeutic areas. A carefully designed analysis plan is an essential prerequisite to a thorough analysis through accurate interpretation of the study data.

Sristek can help you develop efficient and robust trial designs that correctly prepare your statistical data for submission. A thorough quality review process ensures all analyses are accurate and complete. Our goal is to help you finish your trial on time.

Biostatistics
  • Inputs to Study Design
  • Sample Size & Power Calculation
  • Statistical Methodology
  • Interim Analysis Plan
  • Statistical Analysis Plan
  • Statistical Report

Clinical Programming

  • Safety Assessment
  • Clinical Assessment Report Generation
  • Templates for Tables, Listings & Graphs (TLGs)
  • Dataset Specification
  • Analysis Programming
  • Submission Data Files (SDF)
  • Submission Datasets
  • Initial Stat Tables
  • Interim Analysis
  • Integrated Clinical Safety & Efficacy Summary
  • Exploratory Analysis
 

Clinical Research

Clinical Data Management

Biostatistics and Clinical

Programming

Sristek Academy of Clinical

Research (SACR)

Staffing Solutions

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