Biostats & Programming - PHARMA-STATS

Advanced
Biostatistics

Innovative Clinical
Trial Design

Sample Size Estimation

Expert Statistical
Programming

Adaptive Trials
Methodologies

Comprehensive
Survival Analysis

Oncology
Immunology & Rare Diseases

Pharmacokinetic and
Bioequivalence Studies

Therapeutic
Area Proficiency

Extensive Clinical
Trials Experience

1. Advanced Biostatistics

We use mixed models, advanced methods like Bayesian and estimand-based analysis. All methods follow ICH E9 and respective guidances. Every analysis is pre-specified in the SAP and coded in R.

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2. Innovative Clinical Trial Design

We contribute to your protocol from the start. We define endpoints, estimands, and randomisation structure.
Our designs are built to pass regulatory review.

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3. Sample Size Estimation

We calculate sample sizes for all endpoint types. We provide sensitivity analyses across key assumptions. All calculations come with reproducible R code.

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

We program all tables, listings, and figures in R. Every TLF is independently checked by a second statistician. We deliver programs, logs, and output documentation.

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5. Adaptive Trials Design

We support sample size re-estimation and interim analyses.
We provide DSMB & Interim analysis support. All decision rules are pre-specified in the SAP.

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Comprehensive Survival Analysis

Time-to-Event, Done Right

At PHARMA-STATS, we provide statistical expertise in survival analysis with time-to-event endpoints using robust, reproducible, and regulatory-aligned methodologies, enabling confident clinical and regulatory decisions.

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7. Oncology, Immunology & Rare Diseases

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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Biostatistics

1. Advanced Biostatistics

2. Innovative Clinical Trial Design

3. Sample Size Estimation

4. Expert Statistical Programming

5. Adaptive Trials Design

Comprehensive Survival Analysis

7. Oncology, Immunology & Rare Diseases

8. Pharmacokinetic and Bioequivalence Studies

9. Therapeutic Area Proficiency

10. Extensive Clinical Trials Experience

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