Statistical Analysis & Risk Assessment
We support e.g. pharmaceutical and biotechnology projects in the statistical evaluation of quality, process and scientific data as well as in data-based decisions. 
 

• Data distribution & variability – Are contamination values, analysis results or process parameters within the expected range or is there a noticeable change? 
• Probability & Risk Assessment – What is the probability that a critical parameter will exceed a defined threshold? 
• Specifications & Acceptance Criteria – Does a product or process meet a defined criterion with sufficient statistical certainty? 
• Comparison of processes or conditions – Is the difference between processes, batches, suppliers or conditions statistically relevant? 
• Trend analysis – Does the data show a systematic change or a possible trend? 
• Outlier assessment – Is an abnormal value an isolated case or a possible signal of a systematic problem? 
• Confidence intervals & uncertainty – How reliable is the statistical statement and how great is the remaining uncertainty? 
• Data Visualization & Interpretation – How can complex data be presented in an understandable way and used for quality and project decisions? 

Goal: To convert complex data into a comprehensible quantitative basis for quality, risk and process decisions.