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Standardized process for every step of the way






DATACLin’s Biostatics team is experienced and skilled in a board range of therapeutic areas. They can help you to design, implement, evaluate and provide reporting of any Phase (I-IV) of clinical trials and health surveys and also to select the most appropriate design to meet the objectives of your study in accordance with the relevant regulatory bodies’ requirements.

Our Biostatistical services can be customized to your individual needs ranging from statistical analysis plan and sample size calculation, to an in-depth Biostatistical support.

DATACLin team will partner with your organization every step of the way.


Biostatistics Services

  • Protocol Development/ Aspects of clinical trial design
  • Sample Size Calculations/ Statistical power determination
  • Statistical consulting/ Regulatory and advisory meeting support
  • Data Monitoring Committee (DMC) support including committee selection, statistician representation, and charter preparation
  • Randomization Schedule Preparation (Fixed/ Interactive)
  • Statistical Analysis Plan (SAP) Development
  • Statistical Tables, Listings and Graphs
  • Interim Analysis/ Preliminary Analysis
  • Statistical Analyses/ Results interpretation and presentation
    • Topline Analysis Package (delivery within 3 business days of database lock)
    • Final Analysis Package (delivery within 10 business days of database lock)
  • Statistical Review of Clinical Study Reports (CSR)
  • Pooled analyses
  • Meta-analyses
  • Data mining/ Exploratory analyses
  • Integrated Summaries of Safety and Efficacy (ISS/ISE)
  • Quantitative epidemiology including patient registries