PHARMA-STATS

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STORY of PHARMA-STATS

India’s First 100% R-Native Biostatistics CRO

Founded in 2013 by Dr. Nirali Mehta, PHARMA-STATS is a senior-led biostatistics and biometrics CRO delivering regulatory-ready statistical support for global pharma and biotech.

Built as a fully R-native organization, our workflows are designed for reproducibility, transparency, and audit readiness—aligned with FDA, EMA, MHRA, and DCGI expectations.

We support clinical trials end-to-end, including sample size, randomization, SAP, TLF programming, and data-driven statistical analysis, across 200+ projects and 18+ therapeutic areas.

We follow a 'white-box' approach-every line of code and data transformation is fully traceable, enabling confident regulatory review.

Our Mission

To deliver high-quality, reproducible biostatistics and biometrics that support robust clinical development and regulatory decision-making.

PHARMA-STATS is a specialist, 100% R-based boutique CRO, focused on statistical integrity, transparency, and submission-ready deliverables across clinical and analytical studies.

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Pharma, Biotech, CRO clients

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Experience in Therapeutic Areas

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Automation Tools for Pharma R&D

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Trained Pharma Professionals and Statisticians.

WITH YEARS OF EXPERIENCE
Pharmaceutical Statistics Solutions
Reliable, Adaptive, Economical and Future-Ready
100% R-Based Biostatistics and Programming CRO

Built for Regulatory Submissions

PHARMA-STATS operates as a 100% R-based biostatistics CRO, delivering end-to-end statistical support across clinical and analytical research. Our work is grounded in scientific rigor, reproducibility, and regulatory-focused execution.

We work within a validated, GxP-aligned R environment, where analyses are developed through structured workflows with defined controls. Our approach follows principles from R Validation Hub, practices discussed at PHUSE and PharmaSUG, and aligns with ICH E9 and 21 CFR Part 11 expectations.

What This Means for Your Study

Every analysis we deliver is…

R BASED SERVICE
Smart, Scalable, and Secure Software
Our Products

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“Bioequivalence: A Single Click Away”

Looking to fast-track bioavailability and bioequivalence (BA/BE) studies without diving into the weeds of programming or statistics? Say hello to PS-AVTAR — the tool designed to get you from raw data to results in just 3 clicks.

What You Get:

  • No coding? No problem.
  • No biostatistics knowledge? Don’t sweat it.
  • In 7-10 minutes, get fully processed PK & BE results and graphs, ready for action.

Impressive Milestones

A leading biostatistics training institute in India, shaping future-ready statisticians for pharma and clinical research. 1000+ professionals trained in applied, industry-focused biostatistics.

Transforming clinical trial analysis through automation, and 100% R-based workflows backed by experienced statisticians and validated, GxP-aligned processes for reliable, regulatory-ready submissions.

Developed in-house tools (PS-AVTAR, PS-eDISH) to streamline complex statistical analysis and accelerate drug development workflows.

200+ clinical and analytical projects across 18+ therapeutic areas—partnering with global pharma, biotech, and CRO organizations.

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Training

PHARMA-STATS: Shaping the Future of Biostatistics in Clinical Research

PHARMA-STATS develops industry-ready biostatisticians through structured training aligned with real-world clinical research.

Our programs offered in offline and virtual formats are built on statistical design and analysis using R programming for clinical research, combined with various biostatistical methods and regulatory understanding. Participants gain hands-on experience in applying R for clinical trial design, analysis, and submission-ready outputs.

With a strong focus on applied learning, PHARMA-STATS has trained professionals who now contribute across pharma, CRO, and healthcare organizations.

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What Our Clients Say About Us

When should you Contact PHARMA-STATS?