Biostatistics

At Pharmnova, our Biostatistics Services provide rigorous statistical expertise to support clinical trials, pharmacovigilance, and regulatory submissions. By combining advanced methodologies with a deep understanding of regulatory requirements, we help you derive meaningful insights and make evidence-based decisions to drive the success of your projects.

Our Biostatistics Services Include:

Study Design and Statistical Consulting

Assistance with protocol development, sample size calculations, and statistical methodology to ensure robust study designs that meet your objectives.

Statistical Analysis Plan (SAP) Development

Preparation of detailed SAPs, including specifications for datasets, tables, listings, and figures (TLFs), to align with regulatory requirements.

Interim and Final Data Analysis

Execution of interim and final analyses to evaluate study progress, ensure data quality, and generate key insights for decision-making.

Randomization and Blinding

Development of randomization schemes and implementation of blinding processes to maintain trial integrity and reduce bias.

Statistical Programming

Expertise in statistical programming using SAS, R, and other tools to generate reliable and compliant datasets and analysis outputs.

Compliance with Regulations

Ensuring adherence to regulatory and international guidelines like ICH.

Real-World Evidence and Post-Marketing Analysis

Statistical analysis of real-world data to assess product performance, safety, and effectiveness in diverse populations.

Regulatory Submission Support

Creation of statistical sections for regulatory submissions, including integrated summaries of safety (ISS) and efficacy (ISE), in compliance with ICH guidelines.

Why Choose Pharmnova for Biostatistics?

Experienced Team

A team of skilled biostatisticians with extensive industry experience.

Expertise

Expertise in regulatory requirements and global guidelines, including CDISC standards.

Customized Solution

Customized solutions tailored to your unique study and business needs.

Established Process

Advanced analytical tools and techniques for efficient and accurate results.

 

Turning Data into Evidence for Better Decisions!

By partnering with Pharmnova, you gain access to high-quality biostatistical support that transforms your data into actionable evidence, ensuring the success of your clinical studies and regulatory submissions.

Let Pharmnova’s biostatistics team bring clarity to your data and confidence to your decisions.