Stat-Expert Solutions
Clinical Studies
Biometry/Biostatistics is an integral part of all clinical studies. Only through adequate biometry within clinical trials is it possible to demonstrate effectiveness, evaluate diagnostic procedures, estimate side effects, and verify scientific hypotheses. In a clinical study, a medication, treatment modality, or medical product is examined for its efficacy and safety.
Statistical and biometric procedures play a crucial role in this context, and I am here to assist you with my expertise.
Allow me as medical or trial statistician to support you in the statistics and analysis of your clinical studies.
I provide professional and quality-assured assistance in all cases
Feel free to submit a non-binding inquiry, and I will get back to you promptly.
My Services in Detail for Clinical Studies
Study Protocol – Investigational Plan (CIP)
Formulation and determination of study objectives and primary and secondary endpoints
Defining and advising on an appropriate study design
Establishment of inclusion and exclusion criteria
Professional sample size calculation with sensitivity analysis and documentation for the study protocol submission
Comprehensive creation of the statistical section of the study protocol: hypotheses, definition of planned analyses, determination of primary and secondary endpoints, specification of interim analyses, definition of analysis populations (Intent-to-Treat [ITT], Per-Protocol [PP], As-Treated [AT], Safety), handling of missing data and dropouts
Determining the randomization procedure
Data collection
Reviewing the data collection forms to ensure that they are accurate and complete
Providing guidance on the methods for collecting and recording the data, including the methods for minimizing bias and errors
Reviewing the data as it is collected to ensure that it is consistent with the study protocol and to identify any discrepancies or errors
Statistical Analysis Plan (SAP)
Accurate description of study evaluations (demographics and baseline characteristics, efficacy, safety)
Description of the study design, primary and secondary endpoints
Description of derived variables
Appropriate selection of methods for handling missing data Precise and comprehensive description of the statistical methodology, including power analysis
Analysis of covariates, prospective specification of subgroup analyses
Sensitivity analyses
Specification for analysis and programming Enumeration of all Tables, Listings, and Figures (TLF) with blank templates
Comprehensive statistical analyses
Description of the study population
Descriptive and exploratory statistics
Developing and implementing statistical methods for analyzing the data, including methods for handling missing data and for dealing with outliers
Conducting statistical tests to determine whether the results are statistically significant
Generating graphs and tables to help visualize the results
Interpreting the results in the context of the study goals and objectives
Analysis of primary and secondary endpoints
Application of simple and complex methods (e.g., Mixed Model, MMRM, GLM, etc.) for confounder adjustment
Bayesian methods applied when appriate
Programming of the complete analysis in SAS, R, SPSS, or Stata
Report Writing
Preparation of the statistical report
Summarizing the results of the statistical analyses in a clear and concise manner
Preparing tables, figures, and other visual aids to help present the results in an easy-to-understand format
Comprehensive creation of the statistical chapters for the clinical report
Assisting with the preparation of abstracts, posters, and manuscripts for publication in scientific journals