Biostatistics
CROs play a crucial role in the pharmaceutical and biotechnology industries by providing a range of services to support clinical trials. Among these services, biostatistics is a cornerstone, ensuring data integrity, analysis accuracy, and regulatory compliance. Here are some key biostatistics services offered by CROs
Study Design and Protocol Development
Sample Size Calculations: Determining the optimal number of participants required for a study to achieve statistical power.
Statistical Analysis Plan (SAP): Creating a detailed blueprint for data analysis, outlining methods, variables, and statistical tests.
Protocol Review: Ensuring that the study design is statistically sound and aligns with regulatory guidelines.
Statistical Analysis
Descriptive Statistics: Summarizing data using measures like mean, median, mode, standard deviation, and frequency distributions.
Inferential Statistics: Drawing conclusions about a population based on sample data using hypothesis testing, confidence intervals, and regression analysis.
Survival Analysis: Analyzing time-to-event data, such as survival rates or time to recurrence.
Advanced Statistical Techniques: Employing specialized methods like meta-analysis, Bayesian statistics, and machine learning as needed.
Report Generation
Table, listing, and figure (TLF) generation: Creating standardized tables, listings, and figures for regulatory submissions and clinical reports.
Clinical study report (CSR) generation: Preparing comprehensive reports summarizing the study design, methods, results, and conclusions.
Regulatory submission preparation: Assisting in the preparation of regulatory submissions to health authorities, such as the FDA or EMA.
Automation and Efficiency
Macro programming: Developing macros to automate repetitive tasks and improve efficiency.
Data quality checks: Implementing automated data quality checks to ensure data accuracy and consistency.
Data visualization: Creating visualizations (e.g., graphs, charts) to help interpret and communicate results.
Regulatory Compliance
Adherence to standards: Ensuring compliance with regulatory guidelines, such as the Good Clinical Practice (GCP) standards and data standards like SDTM and ADaM.
Documentation: Maintaining comprehensive documentation of programming activities to support audits and regulatory inspections.