From Estimation → To Esteem

Precision Statistics for High-Stakes Decisions

We help pharma teams design smarter trials, accelerate submissions, and unlock insights—combining classic biostatistics with modern AI.

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Biostatistician reviewing clinical trial dashboards on multiple monitors

What we do

From study design to submission, built on rigorous methods and reproducible code.

Clinical Trial Design & Support

  • Study Design & Sample Size Calculation
  • Statistical Analysis Plan Development
  • Adaptive Study Design
  • Protocol & CSR writing support
  • Subgroup and sensitivity analyses
  • TFLs Shells Preparation & Review
  • Regulatory Submission Support
  • Topline Results plan and reporting
  • Missing Data Handling & Imputation Tecniques
  • Data Monitoring Committee (DMC) services for Safety and Efficacy Decisions

Exploratory & Supporting Analyses

  • General Statistical consulting
  • Simulation studies to explore "What if" scenarios
  • Multiplicity Control Methods
  • Publication support and Ad-hoc Analyses
  • Real World Data analysis
  • Meta-analysis and pooled analyses
  • Bayesian analyses
  • Disease Progression Modeling
  • Biomarker and Surrogate Endpoint Analysis

AI/ML Methods Applications

  • Use ML/LLMs to speed reviews
  • Reproducible pipelines
  • Explainable models
  • RWE analysis
  • Safety signal detection
  • Patient stratification
  • Predictive modeling
  • Intelligent Data Monitoring

About us

We’re a team of statisticians and programmers with experience across NCS,oncology and rare disease. We believe in clarity, quality, efficiency, and collaboration.

  • Senior PhD leadership
  • Verified QC workflows
  • Transparent communication

Credentials

  • CDISC / GCP Proficiency
  • Deep knowledge of regulatory guidelines and standards (FDA, EMA, ICH)
  • Extensive experience in the design and analysis of clinical studies
  • More than 20 years of collaboration experience working with scientists from different backgrounds
  • Experience with major EDC, eTMF, and CTMS platforms
  • 20+ years of programming Experience in SAS & R
  • Working Experience with ML/AI tools and frameworks

Contact us

Tell us about your study or analytics need. We’ll reply within 1 business day.

You can reach us directly at