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. - Â
- 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.Â
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.
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.
Key Features:
- Customizable: Tailor it to fit your study’s exact needs.
- Seamless Interface: User-friendly for even the most non-tech-savvy.
- Accurate & reliable for all your BA/BE studies.
Why It’s a Game-Changer:
- Speed Up Your Trials: Cuts down the time to process and analyze bioequivalence data.
- Save Money: Get rid of external dependencies like CROs or dedicated biostatisticians.
- Stay On Budget: Pocket-friendly and efficient.
Who Should Use It?
Pharmaceutical sponsors looking to streamline their non-submission or pilot studies.
In short: If you want to understand your formulation faster, cleaner, and without needing statistical skills, PS-AVTAR is your go-to tool for effortless bioequivalence statistical analysis.Â
Do multiple trial-and-error runs and optimize your formulation faster with this powerful statistical tool. It streamlines your process, saving you time while enhancing precision and efficiency in every step of your bioequivalence study.
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.
- Identify Quick Patient Risk: Instantly spot outliers and trends that signal hepatotoxicity.
- Clear Data Visualization: Effortlessly see complex liver function data in an easy-to-digest format.
- Customizable: Tailor the analysis to fit your needs.
- No Programming Needed: Zero coding or biostatistics skills required.
- 3 Clicks to Results: Get liver toxicity analysis fast.
- User-Friendly: Simplifies complex data for faster, informed decision-making.
- Early Detection: Identify liver issues before they escalate.
- Streamlined Analysis: Saves you time and resources.
- Improves Patient Outcomes: Quick identification means quicker action, improving patient care and safety.
- Medical Practitioners, Hospitals, and Pharma Companies looking for a seamless, cost-effective solution to monitor liver function and support clinical decisions.
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.
What It Does:
- Instant Method Validation: Automated, 5-minute validation for your analytical procedures—no coding needed.
- Crystal Clear Results: Get quick insights with data visualizations that make complex analytics easy to digest.
- Totally Custom: Tailor your analysis to fit your exact needs—perfect for FDA, EMA, ANVISA, and CDSCO compliance.
Features:
- No Coding? No Problem: Zero biostatistics skills required—just plug and play.
- 5-Minutes to Data: Full method validation results in 5 minutes, with zero hassle.
- Super User-Friendly: Let the tool handle the tough stuff while you focus on making decisions.
Benefits:
- Speed Meets Precision: Validate your analytical methods fast, keeping you ahead in pharma R&D.
- Save Time & Money: Skip the CROs and external biostatisticians. We’ve got you covered.
- Stay Regulatory-Ready: Effortlessly align with global standards like FDA, EMA, and ANVISA to stay ahead in your submissions.
Who Should Use It?
Pharma R&D teams, regulatory affairs pros, and biostatisticians who need validated methods, compliance-ready solutions, and fast results—without the headache.
"Validated Methods. Proven Quality. Regulatory-Ready."
Streamline your validation process with TrendAnalytica—your go-to tool for fast, reliable, and compliance-aligned method validation.
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.
What It Does:
- Instant, Audit-Ready Randomization: Stratified, Block, or Site-level—done in under 3 minutes.
- Supports IWRS & Blinding: Designed for seamless integration with your trial workflows.Â
- Plug-and-Play Simplicity: Just input your parameters—RandomizeX does the rest.
Key Features:
- No Programming Needed: No macros, no scripts—zero tech hassle.Â
- Fully Customizable: Tailored to meet any protocol or trial design.Â
- Globally Engineered: Built in India, with quality that meets global clinical standards.
Benefits:
- Faster Trials: Cut setup time drastically with 3-minute randomization runs.
- Full Compliance: Audit-ready outputs for all regulatory bodies.
- Cost-Effective: Saves your time and operational budget.
- Reproducibility Guaranteed: Validated outputs every single time.
Who Should Use It?
Biostatisticians, Clinical Ops Teams, CROs, and Pharma professionals who need a reliable, compliant, and fast randomization tool—without the coding baggage.
"Randomize Faster. Smarter. Compliant. — That’s RandomX."