Biostatistics for Clinical Trials

In today’s clinical research environment, the success of a trial depends on innovative study designs, robust standardization, and the seamless integration of modern data and report workflows. =

We leverage cutting-edge methodologies and tools to ensure our deliverables are fully aligned with sponsors’ clinical goals, CDISC standards and FDA/EMEA guidelines.

Core Expertise

  • Clinical Trial Design : Design, simulation, and execution
  • Statistical Planning : Sample size estimation, power analysis and adaptive trial optimization
  • Regulatory Compliance :        CDISC data mapping, standardization, and preparation for analysis-ready datasets
  • Statistical analysis :   Development of rigourous, publication-ready Statistical Analysis Plans (SAPs)
  • Analysis & Report : Design of Tables, Figures and Listings (TFLs), reporting workflows compliant with ICH E9(R1) for Clinical Study Reports (CSRs)
  • Scientific Impact : Enhancing research visibility through high-impact publicationsin in peer-reviewed journals

Added Value

  • ClinicDesign & Simulation :

Solid experience in complex trial designs tailored to therapeutic areas, development phases, and sponsor goals.

  • Advanced statistical methods ,

Expertise in:

  • Group-sequential methods
  • Multiple (co-)primary endpoints
  • Multiple comparisons
  • Survival analysis
  • (Cluster-)longitudinal data
  • Propensity score methods
  • Inverse probability weighting
  • Machine learning & deep learning for trial optimization

 

  • Standard Operating Procedures (SOPs)
    All processes follow strict SOPs in line with global regulatory standards, including CDISC ADAM, ICH E3, ICH E9(R1) and ICH E6,
Disign clinical trials
Analysis and Reporting
Examples/Use Cases