PHARMA-STATS

Analytical Platforms for Drug Development

Your Team Should Not Wait for a Statistician to Get a Statistical Answer.

PHARMA-STATS built 10+ validated R Shiny tools so that your formulation, analytical, regulatory, clinical and QC teams can run submission-ready statistical analyses themselves.

No coding. No programming knowledge. No waiting. Just your data and your answer in minutes.

The Problem Every Pharma Team Knows

  • Your formulation scientist finishes a dissolution study.
    Now they wait – for a statistician to run the bootstrapping analysis.
  • Your clinical research scientist reviews a dissolution study.
    Now they wait – for a statistician to run the bootstrapping analysis.
  •  
  • Your regulatory affairs team receives an EMA query.
    Now they wait – for a biostatistician to analyses and prepare the response.
  • Your Analytical lab completes a method validation.
    Now they wait – for biostatistician to run the trend analysis and prepare the report. 

Waiting costs time. Time costs money.
In drug development, it also costs approvals.

We built our tools to eliminate that wait.

1. Rapid Bioequivalence Analysis
(7-Minute Run Time)

“Bioequivalence: A Single Click Away”

Bioequivalence Analysis — Done in 7 Minutes

Who is this for?
Regulatory affairs managers and BA/BE study coordinators
who need a BE conclusion quickly — without waiting for
a biostatistician to run the analysis.

2. Liver Function Monitoring System

Comprehensive Liver Monitoring at Your Fingertips!

Introducing PS-eDISH – the ultimate tool for visualizing liver function data, making hepatotoxicity detection a breeze. No coding or stats knowledge required—just 3 clicks to get all the insights you need.

3. Statistical Solutions for Analytical Procedures and Validation (ADL)

TrendAnalytica: Fast, Validated, and Regulatory-Ready Method Validation Statistical Tool

The fastest statistical software designed to provide validated methods for Analytical Method Validation and ensure full regulatory compliance. In just 5 minutes, get fully processed and FDA, EMA, and ANVISA-compliant stats results—no coding needed. Whether you’re in pharma R&D or prepping regulatory submissions, TrendAnalytica ensures your methods are validated, precise, and meet global standards, every single time.


4. RandomX — Effortless, Compliant Randomization in Just 3 Minutes!

Introducing RandomX – your next-gen dashboard for IWRS, Blinding, and Clinical Trial Randomization that delivers speed, precision, and full regulatory compliance-no coding required.