Statistics for AMG Studies

Comprehensive statistical support throughout all study phases At the outset, we assist in the precise statistical definition of endpoints. We help define primary and secondary endpoints clearly, ensuring that the research question is answered accurately and the interpretation is secured. We provide guidance in selecting the appropriate study design. Whether it is a randomized controlled trial or an observational study, we determine statistically which design best addresses the scientific question and is practical to implement. A key component is sample size calculation. We determine the necessary number of participants based on effect size, power, and significance level, thereby creating a solid foundation for meaningful results. During the study, we support you with Data Monitoring Committees (DMCs) and Data and Safety Monitoring Boards (DSMBs). In the analysis phase, BioStats GmbH conducts the statistical evaluation of study data. We apply appropriate methods, systematically address potential influencing factors, and prepare the results in a transparent and traceable manner. In addition to statistical rigor, we place emphasis on medical context, ensuring that results are both scientifically valid and practically interpretable. We also prepare study results in standardized formats such as tables, figures, and listings (TFLs). Our reporting is designed to make even complex analyses understandable while meeting the expectations of scientific audiences and the requirements of regulatory authorities alike.

In this way, BioStats GmbH ensures that AMG studies are scientifically robust, carefully planned, conducted, and analyzed – from start to finish.