Design Procedures

• Clinical study design – Advising on the most appropriate study design and perform the adequate sample size calculation.
• Protocol – In collaboration with clinical partners to develop the clinical trial protocol according to scientific guidelines within regulatory frame
• CRF– Supporting services to the e-CRF development
• Randomization – Creation and implementation of randomization plan

Statistical Analysis

• Statistical Analysis Plans – Development of detailed SAP in accordance to ICH E9 and ICH E9 addendum. Creation of Tables, Lists and Figures mock shells, for clinical study reports.
• Statistical Analysis Expertise –Experienced across most common, advanced and modern statistical methods. Some of them are:
  • MMRM – Adjusting of longitudinal nature data by producing fixed and mixed effects models across phases and indications. Experience in handling non-convergence of models and assessing the best choice of model options.
  • Multiple Imputation– Experience of various types of missing data models, including assuming Missing At Random (MAR) or not MAR imputation and tipping point analysis methods.

Study Results

• Physical presence of interpretation of statistical analysis is considered to be an essential procedure for ASTAT.

• In collaboration with clinical partners to develop the Clinical Study Report and study manuscript

Biostatistical Trainings

Customized trainings tailored to your needs.

Sample topics of our expertise:

• Introduction to Biostatistics
• Power and sample size calculations theory
• Epidemiological measures
• Experimental designs
• Hypothesis testing and Confidence Intervals (CI)
• Longitudinal nature data analysis
• Survival Analysis (K-M Figures, Cox models, Hazard Ratios)

Special Projects

• Meta-analysis
• Investigator-Initiated Studies
• Partial services (design, consulting, analysis) for Phase II – IV trials
• Audit/Quality Control