Biostatistics and Data Management
We offer comprehensive biostatistics and data management services to ensure accurate, reliable, and regulatory-compliant data handling throughout the clinical study process. From study design to data analysis, our expertise helps drive precise and reliable results.
- Study design with sample size calculations
We design clinical studies that not only control the type I error rate but also include precise sample size calculations to ensure statistical power and validity. Our approach optimizes study efficiency and helps avoid under- or over-sampling, balancing between cost and scientific integrity.
- Writing the Statistical Analysis Plan (SAP)
We develop detailed Statistical Analysis Plans that outline the methods and strategies for analyzing study data. These plans ensure that data analysis is aligned with study objectives, regulatory standards, and statistical rigor.
- Interim and final statistical analysis
Our team conducts both interim and final analyses, providing insights into study progress and final outcomes. These analyses are performed using advanced statistical techniques to ensure robust and reliable conclusions.
- Paper and eCRF design and development
We design and develop both paper-based and electronic Case Report Forms to ensure accurate and efficient data capture. Our forms are tailored to each study's specific requirements, ensuring compliance with data collection standards.
- Data Management
We provide end-to-end data management services, including data entry, validation, and cleaning, ensuring high data quality and integrity. Our systems are compliant with regulatory requirements, and we ensure that all data is handled securely and efficiently.