Story of PHARMA-STATS
Since we kicked off in 2013, PHARMA-STATS has been on an adventurous ride, constantly evolving and pushing the boundaries in biostatistics, programming, statistical tools development, and training for the entire drug development process. Check out our journey and see the impact we've made along the way.
Our Mission
We are committed to advancing the field of biostatistics and shaping future leaders through specialized training and comprehensive statistical services.
Clients
Trained Pharma Professionals and Statisticians.
Therapeutic Areas
Workshops
Advanced Biostatistics
Stay Ahead, Stay Smart
At PHARMA-STATS, we're all about staying ahead of the curve in biostatistics. We don’t just stick to the tried-and-true methods; we’re constantly learning, adapting, and embracing the latest trends like Data Visualization and Automation. Our mission? To provide innovative, efficient, and regulatory-compliant biostatistical solutions that keep your clinical trials running smoothly.
Innovative Clinical Trial Design
Shaping the Future of Trials
We’re all about pushing boundaries at PHARMA-STATS. That’s why our trial designs are built with innovation in mind, whether it’s through adaptive designs or cutting-edge methods. We make clinical trials more efficient and effective, especially in complex areas like oncology and rare diseases, where flexibility and speed are key.
Sample Size Estimation
At PHARMA-STATS, we know sample size isn't just about filling seats; it's about striking the perfect balance between statistical power and practical feasibility. The goal? Getting a sample size that can detect real treatment effects without wasting time, resources, or putting patients at unnecessary risk.
Expert Statistical Programming
Mastering the Art of Statistical Programming!
At PHARMA-STATS, we’ve mastered the art of data crunching through cutting-edge programming skills, designed for today’s fast-paced, high-stakes clinical trials. With expertise in R, Python, and SAS, we’re all about delivering fast, precise, and compliant solutions. Our team knows how to make clinical trial data work for you, optimizing both time and resources while ensuring top-notch regulatory compliance.
Adaptive Trials Methodologies
At PHARMA-STATS, we leverage adaptive trial designs to bring flexibility, efficiency, and precision to clinical trials. Adaptive designs allow for real-time adjustments based on the interim results of an ongoing study, offering a dynamic approach compared to traditional fixed designs. These modifications can involve changes to sample size, dose regimens, or patient selection criteria, while maintaining the trial’s statistical integrity.
Comprehensive Survival Analysis
Time-to-Event, Done Right
At PHARMA-STATS, we bring expertise in survival analysis to help you track patient outcomes over time, making it a crucial tool for evaluating the long-term impact of treatments, especially in fields like oncology and chronic disease research. Whether it's understanding how long patients survive, relapse, or progress, we’ve got you covered with advanced, tailored statistical methods that keep your data precise, reproducible, and always aligned with regulatory standards.
Specialized Oncology Expertise
Precision Where It Matters Most
At PHARMA-STATS, we’re more than just statisticians—we’re your go-to experts for navigating the complexities of oncology clinical trials. From early-stage trials to late-phase developments, our services are designed to meet the highest scientific and regulatory standards, ensuring your study is positioned for success from day one.
Pharmacokinetic and Bioequivalence Studies
Streamlined for Success!
At PHARMA-STATS, we’ve perfected the art of designing and analyzing Pharmacokinetic (PK) and Bioequivalence (BE) studies. These are critical for proving the safety, efficacy, and equivalence of drugs, especially in the development of generics. Our cutting-edge statistical methods ensure you meet regulatory requirements with speed and precision, so your product gets to market faster.
Therapeutic Area Proficiency
Precision for Every Field
At PHARMA-STATS, we deliver comprehensive biostatistical support tailored to a wide range of therapeutic areas. With years of experience and a skilled team, we ensure every study is designed and analyzed with laser-sharp precision, while staying aligned with global regulatory standards.
Extensive Clinical Trials Experience
Redefining Biostatistics
At PHARMA-STATS, we deliver specialized biostatistical services that are critical to clinical trial success. Our Unique Selling Proposition (USP) lies in the way we approach clinical trial analysis—from study design to sample size calculation and adaptive trial designs, ensuring that every study is compliant, efficient, and regulatory-ready. With us, it’s not just about meeting standards; it’s about exceeding expectations.
Regulatory Query Statistical Consulting
At PHARMA-STATS, we deliver end-to-end statistical support for regulatory queries, backed by over 20 years of expertise. We’re here to help you navigate the complex regulatory landscape with confidence. Our services are tailored to handle diverse regulatory challenges, from formulation dissolution similarity to advanced analytical queries, clinical trial studies, and both bioequivalence and population bioequivalence.
In-Vitro Convolution Modelling
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
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.
Population Bioequivalence Statistical Support
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.
Peer Review of Previous Studies for a Successful New Trial
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.
Rapid Bioequivalence Analysis
(7-Minute Run Time)
"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.
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.
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.
Training for Statisticians
Get hands-on with real clinical trial data design and analysis! Our biostatistics program covers everything from p-values and hypothesis testing to survival analysis and study designs. Learn through real-life 12+ case studies and practical projects that make you industry-ready fast with various programming skills.
Customized Group Training
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.
Training for Non-Statisticians
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.
R is a game-changer for biostatistics, giving us unmatched power and flexibility to analyze complex data. As an open-source tool, R is continuously evolving, with experts around the world contributing to its improvement. This ensures that we are always using cutting-edge tools and techniques to provide you with the best and most innovative solutions.
PHARMA-STATS: Your Expert Partner in R
We have years of experience working with R and understand the rules and regulations of the pharmaceutical industry. This means we can deliver solutions that are scientifically accurate and meet regulatory standards, making approvals easier and faster.
ps-avta
“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
PHARMA-STATS is India’s only center offering specialized offline biostatistics training for over a decade, shaping the future of biostatistics in India.
Innovative tools PS-AVTAR and PS-eDISH streamline complex statistical analysis, cutting drug development timelines by 70%.
Transforming clinical trials analysis with AI, automation, and open-source tools like R and Python for faster, smarter, data-driven decisions.
Partnered with 110+ global pharma companies, delivering 190+ clinical trials across 15+ therapeutic areas, ensuring regulatory success globally.
Training
PHARMA-STATS: Shaping the Future of Biostatistics in India
Since 2013, PHARMA-STATS has set the gold standard for biostatistics training and consulting in India. With around 500 biostatisticians alumni of PHARMA-STATS, now thriving as professional biostatisticians and programmers, are making waves in leading 100 pharma/CRO/Healthcare companies. Our mission is to bridge the gap between academic theory and industry demands.
We are proud to be the ONLY institute in India offering specialized offline biostatistics training tailored specifically for statisticians and clinical professionals since decade. Our hands-on programs cover everything from biostatistical methodology, survival analysis, to regulatory statistical support – equipping you with the skills you need to excel in clinical trials design and analysis in research.
testimonials
What Our Clients Say About Us
Arati Ranade
(Jehangir Clinical Development Center (JCDC))Working with PHARMA-STATS has been a seamless experience. Their exceptional attention to detail, rigorous analysis, and commitment to quality and timeline have consistently exceeded our expectations. They provide accurate, reliable insights that are vital for deciding the clinical study outcome.
Dr. Mamta Soni
(Senior Consultant & HOD Clinical Pathology & Hematology, Apollo Hospitals, Chennai)Very efficient and knowledgeable team. They are easily accessible and would address to any queries with full sincerity. Highly motivated to deliver the end result in the best possible way.
Nidhin George Jacob
(Julius Clinical, Netherlands)Dr Nirali training has been prominent in the past few years. Fortunately, I got an opportunity to be part of an amazing training where she unwrapped the world of statistics for non-statistician like me. Through amazing case studies and exercises, she could illustrate the contents of the statistics to me. Therefore, I would endorse this training to everyone who craves to understand the statistics realm.
Danesh Gadhia
(Director at Morningside Healthcare Ltd, Braunstone)You really went above and beyond to solve this complex issue in a timely manner. I can tell you’re committed to your clients, and our team, and I really appreciate it.
Dr. Vipul Gujrati
(Research Group Leader, Helmholtz Munich (GmbH))Amazing virtual training by PHARMA-STATS, easy to follow with an engaging style of delivery by the tutor. This course explains everything in great detail, with many examples, and is fantastic for a beginner as well as for experienced who wants to brush up the basics without digging into the literature or books. The tutor uses straightforward language to explain the different ideas and terminologies, which is appreciable. Overall, I feel happy about my decision to take this course.
Purvi Chavda
(Haleus Life Sciences LLP)Working with PHARMA-STATS has been an outstanding experience for us. Their expertise in PK Statistic services is excellent, and their attention to detail has significantly enhanced our projects, especially to get rid of unnecessary regulatory queries. The team is incredibly responsive, and always delivering accurate data analysis on time.
Bhumi Vyas
(Clinvigilant Research)PHARMA-STATS team is where you can stop for all your statistical solutions ensuring quality and integrity. Scientifically sound and professional approach of team adds to the quality of your project.
Dr. Raju Chaudhari
(Associate Professor: M G Science Institute, Ahmedabad)Unique course of this kind and that is too in Ahmedabad. Best for Statistics Students who wish to learn Statistics and it's use in Pharmaceutical Industries. Great placement opportunities in Pharmaceutical Industries after doing Pharma-Stats.
Nidhi Shah
(Scientist-I Statistician at PHARMA-STATS, Gujarat)I am working in PHARMA-STATS as a research scientist since 5 years!!! This is the company that gave me the opportunity to start my career as a biostatistician. I must say no one else can give freedom to learn and work in a research field in your own way...I am exploring my knowledge with the best supportive leaders and team. Thank you, Dr. Nirali Mehta, for showing faith in me. Feeling blessed to be a part of PHARMA-STATS. #ProudPSian😎