Biostatistics

At GGAC Research, data drives decisions. Our Biostatistics services form the backbone of successful clinical trials and drug development programs, transforming complex data into meaningful insights. As a full-service Contract Research Organization (CRO), we provide expert statistical support to ensure the scientific integrity, regulatory compliance, and success of your clinical research.

Our Biostatistics Services Include:

Statistical Consulting: Tailored guidance on study design, sample size estimation, and statistical methodologies to optimize trial outcomes.
Protocol and Statistical Analysis Plan (SAP) Development: Expertly crafted protocols and SAPs that ensure alignment with study objectives and regulatory expectations.
Interim and Final Analysis: Comprehensive data analysis throughout all phases of your trial, including interim and final reporting.
Randomization Design and Implementation: Creation of randomization schemes to minimize bias and ensure study validity.
Data Monitoring Committee (DMC) Support: Statistical support for independent data monitoring committees, including data preparation and safety reviews.
Regulatory Submission Support: Preparation of statistical sections for regulatory submissions, including Integrated Summaries of Safety (ISS) and Efficacy (ISE).
Exploratory Data Analysis: Identification of trends and patterns in data to generate new hypotheses and insights.
Real-World Evidence Analysis: Statistical analysis of post-marketing and real-world data to evaluate long-term product safety and effectiveness.

Why Choose GGAC Research for Biostatistics?

Expert Team: Our biostatisticians bring extensive experience across all phases of clinical development and diverse therapeutic areas.
Cutting-Edge Tools: We utilize advanced statistical software and techniques to deliver accurate, high-quality analyses.
Regulatory Expertise: We ensure compliance with global standards, including ICH, FDA, and EMA guidelines.
Custom Solutions: Our flexible approach allows us to design statistical strategies tailored to your unique research needs.
Commitment to Excellence: We prioritize transparency, precision, and scientific rigor in every project we undertake.

Turning Data into Insights, Insights into Success

At GGAC Research, we believe that every data point has a story to tell. Our Biostatistics solutions empower you to make confident, data-driven decisions that accelerate your path to market.

Partner with GGAC Research for Biostatistics expertise that delivers actionable results. Contact us today to learn more.