HUKSA https://validator.w3.org/feed/docs/rss2.html Real-World Data and Evidence Real-world evidence basics Limitations and challenges Application in regulatory and market access Case Study and Practical Exercise Interpreting a mock clinical study report Identifying statistical strengths and limitations Group discussion on decision-making based on data Q&A and clarification session Biostatistics for Non-Statisticians in Pharmaceutical Research Introduction to Biostatistics in Pharma Role of biostatistics in drug development Types of data in clinical research Descriptive vs inferential statistics Common statistical terminology Understanding Data and Variability Mean, median, standard deviation Normal distribution Variability in clinical data Data visualization basics Hypothesis Testing Simplified Null and alternative hypotheses P-values and significance levels Type I and Type II errors Statistical vs clinical significance Confidence Intervals and Interpretation Concept of confidence intervals Interpreting treatment effects Risk ratios and odds ratios Practical examples from clinical trials Clinical Trial Design Basics Randomization and blinding Control groups and comparators Sample size considerations Bias and confounding factors Understanding Statistical Reports Reading tables and graphs Interpreting forest plots and Kaplan-Meier curves Common statistical outputs in regulatory submissions Avoiding misinterpretation Observational studies Improving process capability Trend Analysis and Root Cause Investigation Detecting trends and shifts Out-of-control action plans Linking SPC with deviation management Root cause analysis integration SPC in Validation and Manufacturing SPC in process validation lifecycle Home Main