Biostatistics

Advanced
Biostatistics

Innovative Clinical
Trial Design

Sample Size Estimation

Expert Statistical
Programming

Adaptive Trials
Methodologies

Comprehensive
Survival Analysis

Specialized
Oncology Expertise

Pharmacokinetic and
Bioequivalence Studies

Therapeutic
Area Proficiency

Extensive Clinical
Trials Experience

1. 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.

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2. 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.

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3. 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.

Why Precision Matters

A well-calculated sample size answers the big questions:

Can we detect meaningful differences between groups?
Are the time, resources, and participant numbers worth it?

Undershooting can lead to missed findings (false negatives), while overshooting wastes time and money. At PHARMA-STATS, we make sure your trial size is just right to deliver reliable, actionable results, all while keeping patient care at the heart of the process.

Key Elements in Sample Size Calculation:

Choosing the Right Endpoint:
- Binary Endpoints: Did the event happen, yes or no? We use proportion comparisons to calculate sample sizes for binary outcomes, like symptom relief or disease progression.
- Continuous Endpoints: These look at variables like blood pressure levels. We use a two-sample t-test to calculate the ideal sample size, factoring in the effect size, variability, and significance level.
- Time-to-Event Endpoints: Think survival or relapse. These are analyzed using methods like Kaplan-Meier or Cox proportional hazards models, with sample size based on expected event rates.
Statistical Power: Power determines the likelihood of detecting a true effect, typically set between 80-90%. We make sure your trial is powered to find meaningful differences, no matter the endpoint.
Effect Size and Variability: The more variability in your data, the bigger the sample size you need to detect meaningful differences. We ensure we get this balance right every time.

Why Sample Size is Key

It's more than just a regulatory checkbox. The right sample size ensures ethical study conduct—only enrolling the participants you really need, ensuring you get meaningful data that leads to real-world, actionable insights.

How PHARMA-STATS Optimizes Your Sample Size:

Our sample size calculations aren’t guesswork. We take a holistic approach, balancing statistical theory with patient-centered ethics. Using advanced software and models, we make sure your trial is powered to deliver clinically meaningful results while staying aligned with global regulatory guidelines.

At PHARMA-STATS, we’re here to make sure your trial is scientifically solid, cost-effective, and always focused on patient care.

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4. Expert 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.

Here’s Why We’re Next-Level:

R Programming: Think of R as the Swiss Army knife of statistical programming. From high-impact data visualizations to complex models, we use R to bring clarity and depth to your trial data. With thousands of CRAN packages, we make sure your data is handled with transparency, traceability, and accuracy, ensuring that every analysis we do meets the highest standards of reproducibility.
Python: Fast, efficient, and adaptable, Python allows us to handle massive datasets and execute cutting-edge machine learning models. Whether automating workflows or running predictive analytics, Python gives us the speed and agility needed to accelerate your clinical trials.

SAS*: Our team knows how to leverage its power to handle complex datasets and generate submission-ready reports with zero compromise on quality. *Applicable in cases of Full-Time Employee (FTE) models.

What’s in it for You?

Speed and Scale: Whether your trial involves hundreds or thousands of patients, our programming solutions can scale without losing precision.
Compliance First: Our team delivers statistical analyses fully aligned with the rigorous standards of agencies, ensuring seamless regulatory submissions.
Tailored to Your Needs: Every trial is different, and we design our workflows to match your exact needs—whether it’s automating data cleaning or crunching numbers for interim analyses.

Why It Matters:

In today’s world, data is king. Our R-based solutions have been behind successful regulatory submissions, meaning we’ve helped companies navigate the complex maze of regulatory requirements with confidence. We’re not just coding for the sake of it; we’re coding to win your trials. With tools like Shiny apps and advanced visualizations, we help you make sense of the numbers, empowering your team to make informed, data-driven decisions faster than ever.

Ready to Roll?

Let’s transform your clinical trial data with precision, speed, and innovation. When you choose PHARMA-STATS, you’re choosing a team that’s not only ahead of the curve but actively shaping the future of statistical programming in clinical research.

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5. Adaptive Trials Design

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.

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6. 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.

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7. 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.

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8. 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.

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9. 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.

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10. 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.

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1. Advanced Biostatistics

2. Innovative Clinical Trial Design

3. Sample Size Estimation

4. Expert Statistical Programming

5. Adaptive Trials Design

6. Comprehensive Survival Analysis

7. Specialized Oncology Expertise

8. Pharmacokinetic and Bioequivalence Studies

9. Therapeutic Area Proficiency

10. Extensive Clinical Trials Experience

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