At PHARMA-STATS we use mathematical models to convert in-vitro dissolution data into a form that mimics in-vivo pharmacokinetics, effectively allowing researchers to understand absorption rates, bioavailability, and overall drug efficacy without the need for early-stage human trials.

By integrating complex factors such as drug solubility, dissolution rate, and absorption kinetics, this method offers a detailed simulation of a drug's journey through the body, including how it’s absorbed, distributed, metabolized, and excreted.

Dissolution Similarity Statistical Analysis: Choose PHARMA-STATS for dissolution similarity analysis that combines statistical rigor with proven regulatory success, ensuring your drug formulations are optimized and ready for approval for biowaivers.

Successful Regulatory Query Responses We have an outstanding track record, for successful regulatory query responses for the EMA and MHRA. This expertise showcases our proficiency in handling complex statistical analyses and addressing stringent regulatory requirements, making us your trusted partner for regulatory submissions.

PHARMA-STATS ensures that all PBE analyses strictly adhere to these OGD guidelines, providing accurate, validated results that support the regulatory approval process. This rigorous approach ensures the safety, efficacy, and consistency of generic drugs, thereby facilitating their acceptance by regulatory agencies.

PHARMA-STATS partners with you to develop in-house software solutions, empowering your team with the tools needed for effective and independent population bioequivalence assessments and training.

By partnering with PHARMA-STATS for peer review, you gain a trusted ally that helps turn past failures into stepping stones for success, ensuring your future clinical trials or bioequivalence studies are scientifically robust and ready for regulatory approval.

As your consultant, PHARMA-STATS offers expert guidance and statistical oversight, ensuring every aspect of your study meets high standards of integrity and compliance, making your path to approval smooth and confident.

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.

What It Does:

• 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.

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.

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.
• Plug-and-Play Simplicity:Just input your parameters—RandomX does the rest.

Learn biostatistics anytime, anywhere, at your own pace. Customize your learning schedule, access real-world case studies, and practice exercises. Get expert support along the way and receive a certificate upon completion.

Empower your employees with essential biostatistics skills, from foundational concepts to advanced techniques. Our comprehensive program covers everything from data interpretation to drawing actionable conclusions.

The R Revolution: Analytics for Modern Clinical Trials Step into the world of R programming with our specialized training for clinical trial professionals. Designed for programmers, biostatisticians, and data enthusiasts, this program focuses on dynamic reporting, trial-specific workflows, and efficient data handling. Gain the skills to meet modern clinical research demands with practical, real-world applications.